TOTALIP 10 mg Film-Coated Tablets

Зміст інструкції

1. TOTALIP 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets
   1. What is TOTALIP and what is it used for
   2. What you need to know before taking TOTALIP
   3. How to take TOTALIP
   4. Possible side effects
   5. How to store TOTALIP
   6. Package Contents and Other Information
2. TOTALIP 5 mg chewable tablets, 10 mg chewable tablets, 20 mg chewable tablets, 40 mg chewable tablets
   1. What is TOTALIP and what is it used for
   2. What you need to know before taking TOTALIP
   3. How to take TOTALIP
   4. Possible side effects
   5. How to store TOTALIP
   6. Contents of the pack and other information

TOTALIP 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What TOTALIP is and what it is used for
• 2. What you need to know before you take TOTALIP
• 3. How to take TOTALIP
• 4. Possible side effects
• 5. How to store TOTALIP
• 6. Contents of the pack and other information

1. What is TOTALIP and what is it used for

TOTALIP belongs to a class of medicines called statins, which regulate lipid (fat) levels.
TOTALIP is used to reduce lipid levels in the blood, known as cholesterol and triglycerides,
when a low-fat diet and lifestyle changes have not been successful.
If you are at high risk of cardiovascular disease, TOTALIP can also be used to reduce
this risk, even if your cholesterol levels are normal. During treatment, you should continue
a standard diet to reduce cholesterol.

2. What you need to know before taking TOTALIP

Do not take TOTALIP

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you have or have had a disease that affects the liver
• if the results of liver function tests have shown inexplicably altered values
• if you are a woman of childbearing potential and are not using a reliable method of contraception
• if you are pregnant or planning a pregnancy
• if you are breastfeeding
• if you are using the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking TOTALIP:

• if you suffer from severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and TOTALIP can cause serious muscle problems (rhabdomyolysis)
• if you have had a previous stroke with cerebral haemorrhage or if you have limited fluid reserves in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have experienced recurrent or unexplained muscle pain, a personal or family history of muscle problems
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you regularly consume significant amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

If any of these conditions apply to you, your doctor will need to perform a blood test before and possibly during treatment with TOTALIP to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and TOTALIP”).
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.
During treatment with this medicine, your doctor will carefully monitor that you do not have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, if you are overweight and have high blood pressure.

Other medicines and TOTALIP
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can alter the effect of TOTALIP or the effect of these medicines can be changed by TOTALIP. This type of interaction can reduce the effect of one or both medicines. Alternatively, it can increase the risk or severity of side effects including a wasting condition of the muscles known as rhabdomyolysis, described in section 4:

• Medicines used to change the way the immune system works, e.g. cyclosporine
• Some antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Some calcium antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Leteremovir, a medicine that helps prevent diseases caused by cytomegalovirus
• Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.
• Some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines that are known to interact with TOTALIP include ezetimibe (which lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (pain reliever), colchicine (used to treat gout) and antacids (products against indigestion containing aluminium and magnesium)
• Non-prescription medicines: St John's Wort
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely resume taking TOTALIP. Taking TOTALIP with fusidic acid can rarely cause muscle weakness, soreness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

TOTALIP with food and drink
See section 3 for instructions on how to take TOTALIP. Keep the following in mind:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice a day, as high amounts of grapefruit juice can alter the effects of TOTALIP.

Alcohol
Avoid drinking excessive amounts of alcohol when taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take TOTALIP if you are pregnant or planning a pregnancy.
Do not take TOTALIP if you are of childbearing potential unless you are using effective contraception.
Do not take TOTALIP if you are breastfeeding.
The safety of TOTALIP during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine alters your ability to drive. Do not use tools or machinery if your ability to use them is altered by this medicine.

TOTALIP contains lactose
If your doctor has diagnosed you with an intolerance to certain types of sugar, contact them before taking this medicine.
TOTALIP contains benzoic acid
10 mg coated tablet
This medicine contains 0.0004 mg of benzoic acid per tablet
20 mg coated tablet
This medicine contains 0.0008 mg of benzoic acid per tablet
40 mg coated tablet
This medicine contains 0.0016 mg of benzoic acid per tablet
80 mg coated tablet
This medicine contains 0.0032 mg of benzoic acid per tablet
TOTALIP contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take TOTALIP

Before starting treatment, your doctor will prescribe you a low-cholesterol diet and you should
continue to follow this diet during therapy with TOTALIP.
The usual initial dose of TOTALIP is 10 mg once a day in adults and in children aged
10 years or older. If necessary, this dose may be increased by your doctor until
reaching the dose you need. Your doctor will adjust the dosage at intervals of 4 or more
weeks. The maximum dose of TOTALIP is 80 mg once a day.
TOTALIP tablets should be swallowed whole with water and can be taken at
any time of the day, with or without food. However, try to take the tablets every
day at the same time.
Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

The duration of treatment with TOTALIPis established by the doctor.
If you feel that the effect of TOTALIP is too strong or too weak, consult your doctor.

If you take more TOTALIPthan you should
If you accidentally take too many TOTALIP tablets (more than the usual daily dose),
contact your doctor or the nearest hospital for advice.

If you forget to take TOTALIP
If you forget to take a dose, take the next dose at the correct time.
Do not take a double dose to make up for a missed tablet.

If you stop taking TOTALIP
If you have any doubts about using this medicine, or wish to stop treatment, consult
your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects or symptoms, stop taking your tablets and immediately inform your doctor or go to the nearest hospital emergency room.
Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue and throat, which can cause significant difficulty breathing.
• Serious condition associated with severe skin peeling and swelling, skin blisters, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may become blisters.
• If you experience weakness, soreness, muscle pain or tearing, or a change in urine color, which becomes red-brown, and especially if you do not feel well and have a high fever at the same time, this may be caused by abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, even after stopping atorvastatin; it can be life-threatening and can lead to kidney problems.

Very rare (may affect up to 1 in 10,000 people):

• If you experience unexpected or unusual bleeding or bruising, this may suggest a liver disorder. You should see a doctor as soon as possible.
• Syndrome resembling lupus erythematosus (which includes skin rash, joint disorders and effects on blood cells).

Other side effects that may occur with TOTALIP
Common (may affect up to 1 in 10 people):

• Inflammation of the nasal passages, sore throat, nosebleeds,
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain and back pain
• Changes in laboratory tests for liver function

Not common (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), increased body weight, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels)
• Nightmares, insomnia
• Dizziness, reduced sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (edema), increased body temperature
• Positive urine test for white blood cells

Rare (may affect up to 1 in 1,000 people):

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage

Very rare (may affect up to 1 in 10,000 people):

• Allergic reaction - symptoms may include sudden wheezing and chest pain or a feeling of tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynecomastia (enlargement of the breasts in men). Not known (frequency cannot be estimated on the basis of available data):
• Persistent muscle weakness
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• See a doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Possible side effects reported with some statins (drugs of the same type):

• Sexual dysfunction
• Depression
• Difficulty breathing including persistent cough and/or shortness of breath or fever
• Diabetes. It is more likely if you have high levels of sugars and fats in your blood, if you are

overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TOTALIP

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label or the packaging after
 Exp.  . The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What TOTALIP contains
The active ingredient of TOTALIP is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate)
Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate)
Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate)
Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate)
The other ingredients are:
calcium carbonate (E170), microcrystalline cellulose (E460), lactose monohydrate, sodium croscarmellose,
polysorbate 80 (E433), hypromellose (E463) and magnesium stearate (E572).
The coating of TOTALIP tablets contains hypromellose (E464), macrogol 8000, titanium dioxide
(E171), talc (E553b), simethicone, stearate emulsifiers, thickening agents (methylcellulose, xanthan gum),
benzoic acid and sorbic acid

Description of the appearance of TOTALIP and package contents
TOTALIP 10 mg film-coated tablets are white and round. They are marked
“10” on one side and “ATV” on the other.
TOTALIP 20 mg film-coated tablets are white and round. They are marked
“20” on one side and “ATV” on the other.
TOTALIP 40 mg film-coated tablets are white and round. They are marked
“40” on one side and “ATV” on the other.
TOTALIP 80 mg film-coated tablets are white and round. They are marked
“80” on one side and “ATV” on the other.
Blisters consisting of a polyamide/aluminum and polyvinyl chloride sheet and an aluminum closure sheet with
vinyl heat-sealing lacquer.
The HDPE bottle contains a desiccant and has a child-resistant closure with a press-and-turn cap.
TOTALIP tablets are available in blister packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90,
98 and 100 film-coated tablets and in hospital packs of 50, 84, 100, 200 (10x20) or 500
film-coated tablets and bottles of 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LABORATORI GUIDOTTI S.p.A. – Via Livornese, 897 – PISA – La Vettola
Manufacturer:

• A. Menarini Manufacturing Logistics and Services S.r.l. Campo di Pile – L’Aquila (Italy) Menarini Von Heyden GmbH Leipziger Strasse 7-13 01097 – Dresden (Germany)

TOTALIP 5 mg chewable tablets, 10 mg chewable tablets, 20 mg chewable tablets, 40 mg chewable tablets

Atorvastatin

Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What TOTALIP is and what it is used for
• 2. What you need to know before you take TOTALIP
• 3. How to take TOTALIP
• 4. Possible side effects
• 5. How to store TOTALIP
• 6. Contents of the pack and other information

1. What is TOTALIP and what is it used for

TOTALIP belongs to a class of medicines called statins, which regulate lipid (fat) levels.
TOTALIP is used to reduce lipid levels in the blood, known as cholesterol and triglycerides,
when a low-fat diet and lifestyle changes have not been successful.
If you are at high risk of cardiovascular disease, TOTALIP can also be used to reduce
this risk, even if cholesterol levels are normal. During treatment, you should continue
a standard diet to reduce cholesterol.

2. What you need to know before taking TOTALIP

Do not take TOTALIP

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you have or have had a disease that affects the liver
• if liver function tests have shown inexplicably altered values
• if you are a woman of childbearing potential and not using a reliable method of contraception
• if you are pregnant or planning a pregnancy
• if you are breastfeeding
• if you are using the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking TOTALIP:

• if you suffer from severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and TOTALIP can cause serious muscle problems (rhabdomyolysis)
• if you have had a previous stroke with cerebral haemorrhage or if you have limited fluid reserves in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have experienced recurrent or unexplained muscle pain, a personal or family history of muscle problems
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you regularly consume significant amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4). If any of these conditions apply to you, your doctor will need to perform a blood test before and possibly during treatment with TOTALIP to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and TOTALIP”).

Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be needed for the diagnosis and treatment of this condition.
During treatment with this medicine, your doctor will carefully monitor that you do not have
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high
levels of sugars and fats in your blood, if you are overweight and have high blood pressure.

Other medicines andTOTALIP
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Some medicines can alter the effect of TOTALIP or the effect of
these medicines can be changed by TOTALIP. This type of interaction can reduce the effect
of one or both medicines. Alternatively, it can increase the risk or severity of side
effects including a wasting condition of the muscles known as rhabdomyolysis, described in
section 4:

• Medicines used to change the way the immune system works, e.g. cyclosporine
• Some antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Some calcium antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Leteremovir, a medicine that helps prevent diseases caused by cytomegalovirus
• Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.
• Some medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines that are known to interact with TOTALIP include ezetimibe (which lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (pain reliever), colchicine (used to treat gout) and antacids (products against indigestion containing aluminium and magnesium)
• Non-prescription medicines: St John's Wort
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can

resume taking TOTALIP safely. Taking TOTALIP with fusidic acid
can rarely cause muscle weakness, soreness or pain (rhabdomyolysis). For more
information on rhabdomyolysis see section 4.

TOTALIP with food and drink
See section 3 for instructions on how to take TOTALIP. Keep the following in mind:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice a day because
large amounts of grapefruit juice can alter the effects of TOTALIP.

Alcohol
Avoid drinking excessive amounts of alcohol when taking this medicine. For further details
see section 2. “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take TOTALIP if you are pregnant or planning a pregnancy.
Do not take TOTALIP if you are of childbearing potential unless you are using effective contraception.
Do not take TOTALIP if you are breastfeeding.
The safety of TOTALIP during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine usually does not affect your ability to drive or operate machinery. However, do
not drive if this medicine alters your ability to drive. Do not use tools or machinery if your
ability to use them is altered by this medicine.

TOTALIP contains aspartame
5 mg chewable tablet:
This medicine contains 0.625 mg of aspartame in each tablet
10 mg chewable tablet:
This medicine contains 1.25 mg of aspartame in each tablet
20 mg chewable tablet:
This medicine contains 2.5 mg of aspartame in each tablet
40 mg chewable tablet:
This medicine contains 5 mg of aspartame in each tablet
Aspartame is a source of phenylalanine. It may be harmful to you if you have phenylketonuria, a rare
genetic disorder that causes phenylalanine to build up because the body cannot dispose of it
correctly.

TOTALIP contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take TOTALIP

Before starting treatment, your doctor will prescribe you a low-cholesterol diet and you should
continue to follow this diet during therapy with TOTALIP.
The usual starting dose of TOTALIP is 10 mg once a day in adults and children aged
10 years or older. If necessary, this dose may be increased by your doctor until
reaching the dose you need. Your doctor will adjust the dosage at intervals of 4 or more
weeks. The maximum dose of TOTALIP is 80 mg once a day.
TOTALIP tablets can be chewed or swallowed whole with water and can
be taken at any time of the day, with or without food. However, try to take the
tablets every day at the same time.
Take this medicine following exactly the instructions of your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

The duration of treatment with TOTALIP is established by the doctor.
If you feel that the effect of TOTALIP is too strong or too weak, consult your doctor.

If you take more TOTALIP than you should
If you accidentally take too many TOTALIP tablets (more than the usual daily dose),
contact your doctor or the nearest hospital for advice.

If you forget to take TOTALIP
If you forget to take a dose, take the next dose at the right time.
Do not take a double dose to make up for the missed tablet.

If you stop taking TOTALIP
If you have any doubts about using this medicine or want to stop treatment, consult
your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects or symptoms, stop taking your tablets and tell your doctor immediately or go to the nearest hospital emergency room.
Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction which causes swelling of the face, tongue and throat that can cause significant difficulty in breathing.
• Serious condition associated with severe peeling and swelling of the skin, skin blisters, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may become blisters;
• If you experience weakness, soreness, muscle pain or muscle tearing or changes in urine color, which becomes reddish-brown, and especially if at the same time you do not feel well and have a high fever, this may be caused by abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, even after stopping atorvastatin: it can be life-threatening and can lead to kidney problems. Very rare (may affect up to 1 in 10,000 people):
• If you experience unexpected or unusual bleeding or bruising, this may suggest a liver disorder. You should see a doctor as soon as possible.
• Lupus-like syndrome (which includes skin rash, joint disorders and effects on blood cells).

Other side effects that may occur with TOTALIP
Common (may affect up to 1 in 10 people):

• Inflammation of the nasal passages, sore throat, nosebleeds,
• Allergic reactions
• Increased blood sugar levels (if you have diabetes you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain and back pain
• Changes in laboratory tests for liver function

Uncommon (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), increased body weight, decreased blood sugar levels (if you have diabetes you should continue to carefully monitor your blood sugar levels)
• Nightmares, insomnia
• Dizziness, reduced sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or in the head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (edema), increased body temperature
• Positive urine test for white blood cells

Rare (may affect up to 1 in 1,000 people):

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage

Very rare (may affect up to 1 in 10,000 people):

• Allergic reaction - symptoms may include sudden wheezing and chest pain or a feeling of tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynecomastia (enlargement of the breasts in men).

Not known (frequency cannot be estimated from the available data):

• Persistent muscle weakness
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• See a doctor if you experience weakness in your arms or legs that gets worse after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Possible side effects reported with some statins (drugs of the same type):

• Sexual dysfunction
• Depression
• Difficulty breathing including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high sugar and fat levels in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TOTALIP

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister or the box after
 Exp.  . The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TOTALIP contains
The active ingredient of TOTALIP is atorvastatin.
Each chewable tablet contains 5 mg of atorvastatin (as atorvastatin calcium trihydrate)
Each chewable tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate)
Each chewable tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate)
Each chewable tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate)
The other ingredients are:
calcium carbonate, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose,
pregelatinized starch, mannitol, aspartame, sucralose, grape flavour and magnesium stearate.

Description of the appearance of TOTALIP and contents of the pack
TOTALIP 5 mg chewable tablets are round in shape and are off-white in colour, with
pink-purple spots. They are engraved with the inscription “5” on one side and “LCT” on the other.
TOTALIP 10 mg chewable tablets are round in shape and are off-white in colour,
with pink-purple spots. They are engraved with the inscription “10” on one side and “LCT” on the other.
TOTALIP 20 mg chewable tablets are round in shape and are off-white in colour,
with pink-purple spots. They are engraved with the inscription “20” on one side and “LCT” on the other.
TOTALIP 40 mg chewable tablets are round in shape and are off-white in colour,
with pink-purple spots. They are engraved with the inscription “40” on one side and “LCT” on the other.
TOTALIP tablets are available in blister packs of 30 chewable tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
LABORATORI GUIDOTTI S.p.A. – Via Livornese, 897 – PISA – La Vettola
Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090, Freiburg (Germany)