LOSEDIN 5 mg Tablet

Зміст інструкції

1. Losedin 5 mg tablets, 10 mg tablets
   1. What Losedin is and what it is used for
   2. What you need to know before taking Losedin
   3. How to take Losedin
   4. Possible side effects
   5. How to store Losedin
   6. Contents of the pack and other information

Losedin 5 mg tablets, 10 mg tablets

amlodipine
Generic medicine

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losedin is and what it is used for

Losedin contains the active ingredient amlodipine, which belongs to a class of medicines called
“calcium antagonists” and works by decreasing blood pressure and decreasing the workload on the heart.
Losedin is used:

• for the treatment of high blood pressure (hypertension);
• for the treatment of chest pain called angina (angina pectoris), including a rare form called Prinzmetal's angina or variant angina.

In patients with hypertension, this medicine works by relaxing the blood vessels so that the blood
can flow more easily. In patients with angina, Losedin improves the blood supply to the
heart, which receives more oxygen and thus prevents chest pain. This medicine does not
provide immediate relief from chest pain due to angina.

2. What you need to know before taking Losedin

Do not take Losedin:

• if you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6) or to any other calcium channel blockers;
• if you have very low blood pressure (severe hypotension);
• if you are in shock, including cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body);
• if you have a narrowing of the aortic valve (e.g. severe aortic stenosis);
• if you have severe heart failure after a recent heart attack;
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Losedin if:

• you have recently had a heart attack
• severe increase in blood pressure (hypertensive crisis)
• you have heart problems (heart failure);
• you have liver problems (hepatic insufficiency);
• you have kidney problems (renal insufficiency);
• you are an elderly person and your dose needs to be increased (see “Use in the elderly”).

Children and adolescents
Losedin should not be used in children under 6 years of age, because studies have not been conducted to demonstrate the safety and efficacy of the medicine in pediatric age.

Other medicines and Losedin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
No interactions with pharmacological and laboratory tests are known.
The effects of Losedin may be influenced or influence the following medicines:

• ketoconazole, itraconazole (medicines used to treat fungal infections)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St John's wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (medicine used for infusion to treat severe alterations in body temperature)
• simvastatin (medicine used to lower cholesterol levels)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the way the immune system works) cyclosporine (an immunosuppressant)

The effects of amlodipine on lowering blood pressure are added to the effects of lowering blood pressure, exerted by other anti-hypertensive medicines.

Losedin with food and drink
People taking Losedin should not drink grapefruit juice as grapefruit and its juice can increase the levels of the active ingredient amlodipine in the blood, and this may lead to an increase in the hypotensive effect of Losedin.

Losedin contains Lactose
If your doctor has diagnosed you with lactose intolerance, contact him/her before taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
Losedin is contraindicated in pregnancy, because studies have not been conducted to demonstrate its safety.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, consult your doctor who will assess with you the risks and benefits of treatment with Losedin.
Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or are about to start breastfeeding, inform your doctor before taking Losedin.

Driving and using machines
Losedin may have mild or moderate effects on the ability to drive vehicles or operate machinery, especially at the beginning of treatment.
Do not drive or operate machinery if, after taking Losedin, you experience headache, dizziness, nausea or fatigue.

3. How to take Losedin

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended initial dose is 5 mg of amlodipine once a day. The dose may be
increased to 10 mg of amlodipine once a day.

Use in the elderly
If you are an elderly person, the doctor will carefully evaluate the increase in dosage.

Use in patients with kidney problems (renal insufficiency) and liver (hepatic insufficiency)

• if you have liver problems, treatment with amlodipine should be started with the lowest dosage and any dose adjustment should occur gradually;
• if you have kidney problems you can use Losedin at normal dosages.

Use in children and adolescents
For children and adolescents aged between 6 and 17 years, the recommended initial dose is 2.5
mg of amlodipine once a day. The maximum recommended dose is 5 mg once a day.
The 2.5 mg dose cannot be obtained from Losedin 5 mg because these tablets cannot
be broken into equal parts.
Losedin should not be used in children under 6 years of age.

If you take more Losedin than you should
If you take more Losedin than you should, the following symptoms may occur: a severe
decrease in blood pressure (hypotension) which can also cause shock or an increase
in heart rate (tachycardia).
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of
breath which may develop up to 24-48 hours after taking it.
In case of accidental overdose of Losedin, seek immediate medical attention or go to the nearest hospital.

If you forget to take Losedin
If you forget to take Losedin, skip the dose and take the tablet the next day at the usual
time.
Do not take a double dose to make up for the missed tablet.

If you stop taking Losedin
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Consult your doctor immediately if you experience any of the following side effects after
taking this medicine.
∙ Severe skin reactions, including intense skin rash, hives, redness of the skin all over
the body, severe itching, blister formation, scaling and swelling
of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal
necrosis or other allergic reactions)

Very common side effects

• Edema (which manifests as swelling that can affect various organs (arms, legs, ankles, eye))

Common side effects(may affect up to 1 in 10 people):

• drowsiness, dizziness and headache (especially at the beginning of treatment);
• Palpitations (feeling your heartbeat), hot flashes;
• abdominal pain and nausea;
• feeling tired;
• Altered bowel habits, diarrhea, constipation, indigestion
• Visual disturbances, double vision.

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

• sleep disturbances or mood changes (e.g. anxiety), depression;
• tremor;
• alterations in taste or smell;
• tingling and altered sensation;
• loss of consciousness;
• ringing in the ears (tinnitus);
• decreased blood pressure;
• difficulty breathing;
• irritation or inflammation of the inner wall (mucosa) of the nose (rhinitis);
• cough;
• vomiting;
• dry mouth;
• digestive disorders;
• itchy skin rashes, red patches on the skin, changes in skin color (purpura, skin discoloration, rash);
• excessive sweating (hyperhidrosis);
• hair loss (alopecia);
• pain in the limbs;
• muscle and joint pain;
• muscle cramps;
• back pain;
• urinary disorders, for example increased need to urinate at night or increased frequency of urination;
• chest pain;
• feeling unwell or pain;
• increase or decrease in weight;
• inability to achieve an erection, breast discomfort or breast enlargement in men.

Rare side effects(may affect up to 1 in 1000)

• confusion

Very rare side effects(may affect up to 1 in 10,000)

• low levels of certain blood cells (leukopenia, thrombocytopenia);
• allergic reactions;
• high levels of sugar in the blood (hyperglycemia);
• a disorder called hypertonia which can cause muscle spasms and tremor;
• a nervous condition called peripheral neuropathy which can cause weakness, tingling or tremor;
• heart attack and changes in heart rate (bradycardia, tachycardia, atrial fibrillation);
• inflammation of blood vessels (vasculitis);
• inflammation of the pancreas (pancreatitis);
• inflammation of the stomach (gastritis);
• swelling of the gums;
• inflammation of the liver (hepatitis);
• yellowing of the skin (jaundice);
• increased levels of certain substances in the liver (liver enzymes);
• swelling of the legs, arms, face, mucous membranes or tongue (angioedema);
• skin rashes characterized by redness, spots on the skin, swelling, scaling of the skin and itching (erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke's edema);
• sensitivity to light.

Reporting of side effects
If you experience any side effect, even those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Losedin

Store the medicine at a temperature not exceeding 25 C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 the medicine contains
Losedin 5 mgtablets:

• The active ingredient is: amlodipine besilate. One tablet contains 6.94 mg of amlodipine besilate (equivalent to 5 mg of amlodipine base).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate.

Losedin 10 mgtablets:

• The active ingredient is: amlodipine besilate. One tablet contains 13.87 mg of amlodipine besilate (equivalent to 10 mg of amlodipine base).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate.

Description of the appearance of Losedin and contents of the pack
Losedin 5 mg tablets: pack of 28 tablets of 5 mg
Losedin 10 mg: pack of 14 tablets of 10 mg

Marketing Authorisation Holder:
Eberlife Farmaceutici S.p.A.
Via G. Porzio SNC – 80143 Napoli (Na) - CDN Isola E1
Manufacturer:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1, 03012 Anagni (FR)
September 2022