ALAMUT 2.5 мг/5 мг Капсулы твердые

Содержание инструкции

1. ALAMUT 2.5 mg + 5 mg hard capsules, 5 mg + 5 mg hard capsules, 10 mg + 5 mg hard capsules, 5 mg + 10 mg hard capsules, 10 mg + 10 mg hard capsules
   1. What is ALAMUT and what is it used for
   2. What you need to know before taking ALAMUT
   3. How to take ALAMUT
   4. Possible side effects
   5. How to store ALAMUT
   6. Contents of the pack and other information

ALAMUT 2.5 mg + 5 mg hard capsules, 5 mg + 5 mg hard capsules, 10 mg + 5 mg hard capsules, 5 mg + 10 mg hard capsules, 10 mg + 10 mg hard capsules

Ramipril/amlodipine
Read this leaflet carefully before you start 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 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 ALAMUT is and what it is used for
• 2. What you need to know before you take ALAMUT
• 3. How to take ALAMUT
• 4. Possible side effects
• 5. How to store ALAMUT
• 6. Contents of the pack and other information

1. What is ALAMUT and what is it used for

ALAMUT contains two active ingredients: amlodipine and ramipril. Amlodipine belongs to a group of medicines
called calcium antagonists. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).
Amlodipine works by:

• relaxing and widening blood vessels so that blood can flow more easily. Ramipril works by:
• reducing the body's production of substances that can raise blood pressure;
• relaxing and widening blood vessels;
• making it easier for the heart to pump blood around the body. ALAMUT is used for the treatment of hypertension (high blood pressure), in patients whose blood pressure is adequately controlled with amlodipine and ramipril taken simultaneously at the same dose as in ALAMUT, but as separate medicines.

2. What you need to know before taking ALAMUT

Do not take ALAMUT:

• if you are allergic to amlodipine, ramipril (active ingredients), any other calcium antagonist or any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6). The reaction may be itching, redness of the skin or difficulty breathing;
• if your blood pressure is unusually low or unstable. Your doctor will need to make this assessment;
• if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body);
• if you suffer from heart failure following a heart attack;
• if you have ever had a severe allergic reaction called “angioedema”. The signs include itching, hives, red spots on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
• if you are on dialysis or undergoing any other type of blood filtration. Depending on the machine used, ALAMUT may not be suitable for you;

if you have kidney problems caused by reduced blood flow to the kidneys (renal artery stenosis);

• during the last 6 months of pregnancy (see section "Pregnancy and breastfeeding");
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren; Do not take ALAMUT if any of the cases listed above apply to you. If you are not sure, ask your doctor or pharmacist before taking ALAMUT.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALAMUT. Tell your doctor if any of the
cases listed below apply to you:

• if you have a sudden increase in blood pressure (hypertensive crisis);
• if you are elderly and your dosage needs to be increased;
• if you have problems with your heart, liver or kidneys;
• if you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis);
• if you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization);
• if you are about to be treated with an anesthetic. This may be administered for surgery or dental work. You must stop treatment with ALAMUT one day before; for more information, consult your doctor;
• if you have a high level of potassium in your blood (shown by a blood test);
• if you have a connective tissue disease such as scleroderma or systemic lupus erythematosus;
• if you are taking any of the following medicines used to treat high blood pressure: an “angiotensin II receptor blocker” (AIIRA) (also known as sartans, for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes. aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated in the section “Do not take ALAMUT”.

Children and adolescents
The use of ALAMUT is not recommended in children and adolescents under the age of 18 years, because
there is no information available for this population of patients.

Other medicines and ALAMUT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor if you are taking any of the following medicines, because they may make ALAMUT less effective than necessary:

• medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin);
• medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine or epinephrine. Your doctor will need to check your blood pressure;
• rifampicin (an antibiotic used to treat tuberculosis);
• erythromycin, clarithromycin (antibiotics);
• hypericum perforatum(St. John's wort used to treat depression).

Tell your doctor if you are taking any of the following medicines, because they may increase the
likelihood of side effects if you take them with ALAMUT:
medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen or indometacin and aspirin);

• cancer medicines (chemotherapy), such as temsirolimus;
• medicines to prevent organ rejection after a transplant, such as cyclosporineand everolimus;
• tacrolimus(also used to control the immune response and allow the body to accept the transplanted organ);
• diuretics such as furosemide;
• medicines that can increase the amount of potassium in the blood, such as spironolactone, triamterene, amiloride, potassium salts and heparin(to thin the blood);
• steroid medicines for inflammation, such as prednisolone;
• allopurinol(used to lower uric acid levels in the blood);
• procainamide(for heart rhythm problems);
• ketoconazole, itraconazole(antifungal medicines);
• ritonavir, indinavir, nelfinavir(so-called protease inhibitors, used to treat HIV);
• erythromycin, clarithromycin, trimethoprim and co-trimoxazole(for infections caused by bacteria);
• verapamil, diltiazem(medicines to treat heart problems or high blood pressure);
• vildagliptin(oral medicine that lowers blood glucose levels);
• dantrolene(infusion medicine, used for severe alterations of body temperature).

Tell your doctor if you are taking any of the following medicines, because their action may
be modified by ALAMUT:

• medicines for diabetes, such as oral medicines to lower blood sugar levels and insulin. ALAMUT may lower your blood sugar level. Monitor your blood sugar level while taking ALAMUT;
• lithium (for mental health problems). ALAMUT may raise the level of lithium in your blood. Your doctor will need to closely monitor your lithium levels in the blood;
• simvastatin (a medicine to lower cholesterol). ALAMUT may raise the level of simvastatin in your blood.

Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated in the section “Do not take ALAMUT” and “Warnings and precautions”).

If any of the cases listed above apply to you (or if you are not sure), tell your doctor before taking
ALAMUT.

ALAMUT with food, drinks and alcohol
ALAMUT can be taken with or without food.
People taking ALAMUT should not consume grapefruit or grapefruit juice.
This is because grapefruit and its juice can lead to an increase in the levels of the
active ingredient amlodipine in the blood, which can cause an unpredictable increase in blood
pressure, reducing the effect of ALAMUT.
Drinking alcohol with ALAMUT may cause dizziness or confusion. If you are concerned about how much you can drink
while taking ALAMUT, talk to your doctor, as medicines used to lower
blood pressure and alcohol can have additive effects.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your
doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take ALAMUT during pregnancy.
If you think you are pregnant during treatment with ALAMUT, tell your doctor immediately. Before
planning a pregnancy you should switch to an alternative therapy suitable.

Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. Do not take ALAMUT if you are
breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
ALAMUT may affect your ability to drive or operate machinery. If ALAMUT causes
you to feel unwell, dizzy or tired, or headache, do not drive or operate machinery and contact
your doctor immediately. This may happen especially at the beginning of therapy, or when switching from
other medicines.

3. How to take ALAMUT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
If you feel that the effect of ALAMUT is too strong or too weak, inform your doctor or
pharmacist.
Take the medicine by mouth always at the same time of day, before or after meals. Swallow the capsule
whole with some liquid.
Do not break or chew the capsules.
Do not take ALAMUT with grapefruit juice.
ALAMUT must be taken once a day.
The doctor may modify the dose depending on the effect it has on you. The maximum daily dose is one
capsule of 10 mg + 10 mg.

Elderly
The doctor will reduce the initial dose and adjust the treatment more slowly.

Use in children and adolescents
The use of ALAMUT is not recommended in children and adolescents under the age of 18, because for
this patient population, information is not available.

If you take more ALAMUT than you should
Taking too many capsules can cause a decrease or a dangerous decrease in blood
pressure. You may experience dizziness, lightheadedness, fainting, or weakness. If the drop in blood pressure is so severe, it may
occur shock. The skin may become cold and clammy and you may lose consciousness. Excess
fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath that may
develop up to 24-48 hours after taking it. Inform your doctor immediately or go
immediately to the nearest hospital. Do not drive to the hospital, but have someone accompany you or
call an ambulance. Bring the package of the medicine with you, so that the doctor knows what you have
taken.

If you forget to take ALAMUT
If you forget to take a capsule, skip that dose altogether and take the next dose at the usual time.
Do not take a double dose to make up for the forgotten capsule.

If you stop taking ALAMUT
The doctor will inform you how long you will need to take this medicine. If you stop treatment
before being told to do so, your illness may recur.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking ALAMUT and
consult your doctor immediately because you may need urgent medical treatment:

• swelling of the face, lips or throat that can cause difficulty swallowing or breathing, as well as itching and skin rashes. This could be a sign of a severe allergic reaction to ALAMUT;
• severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.

Tell your doctor immediately if the following occur:

• a fast, irregular or strong heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems including heart attack and stroke;
• shortness of breath or cough. This could be a sign of lung problems;
• a greater tendency to bruise, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple patches, spots on the skin or a greater tendency to infections, sore throat and fever, feeling tired, weak, dizzy or pale. These can be signs of blood or bone marrow problems;
• very severe stomach pain that may radiate to your back. This can be a sign of pancreatitis (inflammation of the pancreas);
• fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These can be signs of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other side effects include:
Tell your doctor if any of the following side effects becomes serious or lasts for more than a few
days.
Common (may affect up to 1 in 10 people):

• drowsiness (particularly at the beginning of treatment);
• palpitations (feeling of a fast-beating heart), hot flushes;
• swelling of the ankles (oedema);
• headache or feeling tired;
• feeling dizzy. This is more likely to happen at the start of therapy with ALAMUT or when you start taking a higher dose;
• fainting, low blood pressure (blood pressure too low), especially when getting up or sitting up too quickly;
• dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
• abdominal pain, stomach pain or cramps, diarrhoea, indigestion, feeling or being sick;
• skin rash with or without swelling;
• chest pain;
• muscle cramps or pain;
• blood tests showing too much potassium in your blood than normal. Uncommon (may affect up to 1 in 100 people):
• changes in mood, insomnia;
• tremor, weakness, pain, feeling unwell;
• vision disturbances, double vision, blurred vision, ringing in the ears;
• cold/runny nose caused by inflammation of the nasal mucosa (rhinitis);
• changes in bowel habits (including diarrhoea or constipation), heartburn, dry mouth;
• hair loss, increased sweating, itchy skin, red spots on the skin, skin discolouration;
• problems with urination, increased need to urinate, especially at night, increased number of times you urinate;
• inability to get an erection, sexual dysfunction in men, reduced sexual drive in men or women;
• discomfort or enlargement of the breasts in men;
• joint or muscle pain, muscle cramps, back pain;
• weight gain or loss;
• balance problems (dizziness);
• itching and unusual skin sensations such as numbness, tingling, prickling, burning or chills (paresthesia), loss of sensation to pain;
• loss or change in the sense of taste of things;
• problems with sleeping;
• feeling depressed, anxious, more nervous than usual or restless;
• blocked nose, difficulty breathing or worsening of asthma;
• a swelling of the intestine called “intestinal angioedema” which presents with symptoms such as abdominal pain, vomiting and diarrhoea;
• loss or decrease in appetite (anorexia);
• increase or irregularity in heartbeat;
• swollen arms and legs. This could be a sign that your body is retaining more water than normal;
• fever;
• an increase in the number of a certain type of white blood cells (eosinophilia), detected during a blood test;
• blood tests showing changes in the function of liver, pancreas or kidneys. Rare (may affect up to 1 in 1,000):
• feeling shaky or confused;
• red or swollen tongue;
• severe peeling or flaking of the skin, itching, rash with swelling;
• nail problems (e.g. loss or separation of a nail from the nail bed);
• rash or bruising;
• hives;
• spots on the skin and cold hands and feet;
• red, itchy, swollen or watery eyes;
• hearing problems;
• blood tests showing a decrease in the number of red blood cells, white blood cells, platelets or in the amount of haemoglobin. Very Rare (may affect up to 1 in 10,000):
• increased sensitivity to sunlight than usual;
• excess sugar in the blood (hyperglycaemia);
• swelling of the gums;
• stomach swelling (gastritis);
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice);
• increased muscle tension;
• inflammation of blood vessels, often with a rash;
• sensitivity to light;
• psoriasis. Not known:
• concentrated urine (dark in colour), feeling unwell or sick, muscle cramps, confusion and convulsions which can be due to inappropriate secretion of ADH (anti-diuretic hormone). If you experience these symptoms contact your doctor promptly;
• tremor, stiff posture, mask-like face, slow movements and a shuffling, dragging walk.

Other side effects reported:
Tell your doctor if any of the following side effects becomes serious or lasts for more than a few
days:

• difficulty concentrating;
• blood tests showing too few blood cells;
• blood tests showing too little sodium in the blood than normal;
• fingers and toes that change colour in the cold and then tingle or feel painful when warmed up (Raynaud's phenomenon);
• slowed or altered reactions;
• change in the perception of smells.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system athttp://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 ALAMUT

Store below 30°C.
Store in the original package to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister 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 ALAMUT contains
The active ingredients are:

ALAMUT 2.5 mg + 5 mg hard capsules
each capsule contains: 2.5 mg of ramipril and 6.934 mg of amlodipine besilate (corresponding to 5 mg of
amlodipine)

ALAMUT 5 mg + 5 mg hard capsules
each capsule contains: 5 mg of ramipril and 6.934 mg of amlodipine besilate (corresponding to 5 mg of
amlodipine)

ALAMUT 10 mg + 5 mg hard capsules
each capsule contains: 10 mg of ramipril and 6.934 mg of amlodipine besilate (corresponding to 5 mg of
amlodipine)

ALAMUT 5 mg + 10 mg hard capsules
each capsule contains: 5 mg of ramipril and 13.868 mg of amlodipine besilate (corresponding to 10 mg of
amlodipine)

ALAMUT 10 mg + 10 mg hard capsules
each capsule contains: 10 mg of ramipril and 13.868 mg of amlodipine besilate (corresponding to 10 mg of
amlodipine)
The other ingredients are: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized starch,
low moisture pregelatinized starch, sodium starch glycolate (type A), sodium stearyl fumarate,
red iron oxide (E172), titanium dioxide (E171), gelatin.
In ALAMUT 10 mg + 10 mg there are also: yellow iron oxide (E172), black iron oxide (E172)

Description of the appearance of ALAMUT and contents of the pack
ALAMUT 2.5 mg + 5 mg hard capsules: hard gelatin capsules, light pink opaque cap, opaque white body.
Capsule contents: white or almost white powder.
ALAMUT 5 mg + 5 mg hard capsules: hard gelatin capsules, opaque pink cap, opaque white body.
Capsule contents: white or almost white powder.
ALAMUT 10 mg + 5 mg hard capsules: hard gelatin capsules, opaque dark pink cap, opaque white body.
Capsule contents: white or almost white powder.
ALAMUT 5 mg + 10 mg hard capsules: hard gelatin capsules, opaque reddish-brown cap,
opaque white body. Capsule contents: white or almost white powder.
ALAMUT 10 mg + 10 mg hard capsules: hard gelatin capsules, opaque brown cap, opaque white body.
Capsule contents: white or almost white powder.
ALAMUT is available in blisters containing 28 capsules.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via Dei Castelli Romani, 22
00071 Pomezia (Rome)

Manufacturers
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (Frosinone), Italy
August 2022