Alamut

Italy
Brand name Alamut
Form capsules, hard gelatin
Active substance / Dosage
AMLODIPINE
RAMIPRIL
Prescription type Prescription only
ATC code
C09BB07
Registration number 044036
Manufacturer SO.SE.PHARM S.R.L. SOCIETA' DI SERVIZIO PER L'INDUSTRIA FARMACEUTICA ED AFFINI

Table of Contents

Package leaflet: Information for the user

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 entire 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 or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 ALAMUT is and what it is used for

ALAMUT contains two active substances: 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 to treat hypertension (high blood pressure) in patients whose blood pressure is adequately controlled with amlodipine and ramipril taken together 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 substances), 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 include itching, skin redness, or difficulty breathing;
  • if your blood pressure is unusually low or unstable. Your doctor will need to assess this;
  • if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient 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". Signs include itching, hives, red spots on 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 have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
    Do not take ALAMUT if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking ALAMUT.

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

  • if you have increased blood pressure (hypertensive crisis);
  • if you are elderly and your dosage needs to be increased;
  • if you have heart, liver, or kidney problems;
  • if you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or due to long-term use of oral diuretics, or after dialysis);
  • if you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization);
  • if you are about to be treated with an anesthetic. This may be administered during surgery or dental procedures. You must stop treatment with ALAMUT one day before; for further information, consult your doctor;
  • if you have high levels of potassium in your blood (shown by a blood test);
  • if you have a vascular collagen 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 antagonist" (AIIRA) (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, or aliskiren. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.

See also information under "Do not take ALAMUT".
Children and adolescents
The use of ALAMUT is not recommended in children and adolescents under 18 years of age, as
no information is available for this patient population.
Other medicines and ALAMUT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Inform your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of ALAMUT:

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

Inform your doctor if you are taking any of the following medicines, as they may increase the
risk of adverse effects when taken with ALAMUT:
medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin);

  • medicines for cancer treatment (chemotherapy), such as temsirolimus;
  • medicines to prevent organ rejection after transplantation, such as ciclosporin and everolimus;
  • tacrolimus (also used to control immune response and allow the body to accept a transplanted organ);
  • diuretics such as furosemide;
  • medicines that increase potassium levels 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 disorders);
  • ketoconazole, itraconazole (antifungal medicines);
  • ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV virus);
  • erythromycin, clarithromycin, trimethoprim, and cotrimoxazole (for bacterial infections);
  • verapamil, diltiazem (medicines to treat heart disorders or high blood pressure);
  • vildagliptin (an oral medicine that lowers blood glucose levels);
  • dantrolene (an intravenous medicine used for severe disturbances in body temperature).

Inform your doctor if you are taking any of the following medicines, as their effects may
be altered by ALAMUT:

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

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

  • if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information under "Do not take ALAMUT" and "Warnings and precautions").

If any of the above conditions apply to you (or if you are unsure), inform your doctor before taking
ALAMUT.
ALAMUT with food, drinks, and alcohol
ALAMUT can be taken with or without food.
People taking ALAMUT must not consume grapefruit or grapefruit juice.
This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable drop in blood pressure, reducing the effectiveness of ALAMUT.
Drinking alcohol with ALAMUT may cause dizziness or confusion. If you are concerned about how much alcohol you can drink while taking ALAMUT, talk to your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your
doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ALAMUT during pregnancy.
If you think you may be pregnant while taking ALAMUT, inform your doctor immediately. Before planning a pregnancy, you should switch to an alternative therapy suitable for pregnancy.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. Do not take ALAMUT if you are
breastfeeding. Inform your doctor or pharmacist before taking any medicine.
Driving and using machines
ALAMUT may affect your ability to drive or operate machinery. If ALAMUT causes you discomfort, dizziness or fatigue, headache, do not drive or operate machinery and contact your doctor immediately. This may occur especially at the beginning of treatment or when switching from other medicines.

3. How to take ALAMUT

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult 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 orally at the same time each day, with or without food. Swallow the capsule whole with
liquid.
Do not break or chew the capsules.
Do not take ALAMUT with grapefruit juice.
ALAMUT must be taken once daily.
Your doctor may adjust the dose depending on how it affects you. The maximum daily dose is one capsule of 10 mg + 10 mg.
Elderly
Your doctor will reduce the initial dose and adjust treatment more slowly.
Use in children and adolescents
The use of ALAMUT is not recommended in children and adolescents under 18 years of age, as information for this patient population is not available.
If you take more ALAMUT than you should
Taking too many capsules may cause a drop in blood pressure or a dangerous lowering of blood pressure. You may experience dizziness, lightheadedness, fainting, or weakness. If the drop in blood pressure is severe, shock may occur. The skin may become cold and moist, and you may lose consciousness. Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion. Contact your doctor immediately or go immediately to the nearest hospital. Do not drive to the hospital; have someone accompany you or call an ambulance. Bring the medicine package with you so the doctor knows what you have taken.
If you forget to take ALAMUT
If you forget to take a capsule, skip that dose completely and take the next dose at your usual time. Do not take a double dose to make up for the missed capsule.
If you stop taking ALAMUT
Your doctor will inform you how long you should take this medicine. If you stop treatment before being instructed to do so, your condition may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following serious side effects, stop treatment with ALAMUT and consult your doctor immediately, as you may require urgent medical treatment:

  • swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, together with itching and skin rash. This could be a sign of a severe allergic reaction to ALAMUT;
  • severe skin reactions including rash, mouth ulcers, 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.

Contact your doctor immediately if you experience:

  • a fast, irregular, or forceful heartbeat (palpitations), chest pain, feeling of chest tightness, or more serious problems including heart attack and stroke;
  • shortness of breath or cough. This could be a sign of lung problems;
  • increased tendency to bruise, bleeding that lasts longer than usual, any signs of bleeding (e.g. bleeding gums), purple spots, skin patches, or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy, or pale. These may be signs of blood or bone marrow problems;
  • severe stomach pain that may radiate to the back. This could 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 may be signs of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the following side effects become severe or persist for more than a few days.
Common (may affect up to 1 in 10 people):

  • drowsiness (particularly at the beginning of treatment);
  • palpitations (awareness of a fast or forceful heartbeat), hot flushes;
  • swelling of the ankles (oedema);
  • headache or feeling tired;
  • dizziness. This is more likely at the start of ALAMUT therapy or when starting a higher dose;
  • fainting, hypotension (low blood pressure), particularly when standing up or sitting down too quickly;
  • dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
  • abdominal pain, stomach ache, diarrhoea, indigestion, feeling sick or vomiting;
  • skin rash with or without swelling;
  • chest pain;
  • muscle cramps or muscle pain;
  • blood tests showing abnormally high levels of potassium in the blood.

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

  • mood changes, insomnia;
  • tremors, weakness, pain, feeling unwell;
  • visual disturbances, double vision, blurred vision, ringing in the ears;
  • cold or runny nose due to inflammation of the nasal mucosa (rhinitis);
  • changes in bowel habits (including diarrhoea or constipation), heartburn, dry mouth;
  • hair loss, increased sweating, skin itching, red spots on the skin, skin discolouration;
  • urinary problems, increased need to urinate, especially at night, increased frequency of urination;
  • inability to achieve an erection, sexual dysfunction in men, reduced sexual desire in men or women;
  • discomfort or enlargement of the breasts in men;
  • joint or muscle pain, muscle cramps, back pain;
  • weight gain or weight loss;
  • balance problems (dizziness);
  • itching and unusual skin sensations such as numbness, tingling, tickling, burning, or chills (paraesthesia), loss of sensitivity to pain;
  • loss or change in the sense of taste;
  • sleep problems;
  • feeling depressed, anxious, unusually nervous, or restless;
  • nasal congestion, difficulty breathing, or worsening of asthma;
  • intestinal swelling called “intestinal angioedema” presenting with symptoms such as abdominal pain, vomiting, and diarrhoea;
  • loss or decrease in appetite (anorexia);
  • increased or irregular heartbeat;
  • swollen arms and legs. This could be a sign that your body is retaining more fluid than normal;
  • fever;
  • an increase in a certain type of white blood cells (eosinophilia), detected during a blood test;
  • blood tests showing changes in liver, pancreas, or kidney function.

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

  • sensation of trembling or confusion;
  • red or swollen tongue;
  • severe peeling or shedding of the skin, itching, skin rash with swelling;
  • nail problems (e.g. loss or separation of a nail from the nail bed);
  • skin rash or bruising;
  • hives (urticaria);
  • skin patches and cold hands and feet;
  • red, itchy, swollen, or watery eyes;
  • hearing disturbances;
  • blood tests showing a reduction in the number of red blood cells, white blood cells, platelets, or in haemoglobin levels.

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

  • increased sensitivity to sunlight;
  • excessive blood sugar levels (hyperglycaemia);
  • swollen gums;
  • abdominal swelling (gastritis);
  • liver function abnormalities, liver inflammation (hepatitis), yellowing of the skin (jaundice);
  • increased muscle tension;
  • inflammation of blood vessels, often with skin rash;
  • light sensitivity;
  • psoriasis.

Not known:

  • concentrated urine (dark in colour), feeling unwell, muscle cramps, confusion, and seizures, which may be due to inappropriate secretion of ADH (anti-diuretic hormone). If you experience these symptoms, contact your doctor promptly;
  • tremor, rigid posture, mask-like facial expression, slow movements, and shuffling gait.

Other reported side effects:
Inform your doctor if any of the following side effects become severe or last longer than a few days:

  • difficulty concentrating;
  • blood tests showing abnormally low levels of blood cells;
  • blood tests showing abnormally low levels of sodium in the blood;
  • fingers of the hands and feet changing colour in the cold, followed by tingling or pain when warming up (Raynaud's phenomenon);
  • slowed or altered reactions;
  • changes in the perception of smells.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 ALAMUT

Store below 30°C.
Keep in the original packaging 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 stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What ALAMUT Contains
The active substances are:
ALAMUT 2.5 mg + 5 mg hard capsules
Each capsule contains: 2.5 mg ramipril and 6.934 mg amlodipine besylate (equivalent to 5 mg amlodipine).
ALAMUT 5 mg + 5 mg hard capsules
Each capsule contains: 5 mg ramipril and 6.934 mg amlodipine besylate (equivalent to 5 mg amlodipine).
ALAMUT 10 mg + 5 mg hard capsules
Each capsule contains: 10 mg ramipril and 6.934 mg amlodipine besylate (equivalent to 5 mg amlodipine).
ALAMUT 5 mg + 10 mg hard capsules
Each capsule contains: 5 mg ramipril and 13.868 mg amlodipine besylate (equivalent to 10 mg amlodipine).
ALAMUT 10 mg + 10 mg hard capsules
Each capsule contains: 10 mg ramipril and 13.868 mg amlodipine besylate (equivalent to 10 mg amlodipine).

The other components are: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized starch, low moisture pregelatinized starch, sodium starch glycolate (type A), sodium stearyl fumarate, iron oxide red (E172), titanium dioxide (E171), gelatin.
ALAMUT 10 mg + 10 mg also contains: iron oxide yellow (E172), iron oxide black (E172).

Description of the Appearance of ALAMUT and Package Contents
ALAMUT 2.5 mg + 5 mg hard capsules: Hard gelatin capsules with an opaque pale pink cap and an opaque white body. Capsule contents: white or almost white powder.
ALAMUT 5 mg + 5 mg hard capsules: Hard gelatin capsules with an opaque pink cap and an opaque white body. Capsule contents: white or almost white powder.
ALAMUT 10 mg + 5 mg hard capsules: Hard gelatin capsules with an opaque dark pink cap and an opaque white body. Capsule contents: white or almost white powder.
ALAMUT 5 mg + 10 mg hard capsules: Hard gelatin capsules with an opaque red-brown cap and an opaque white body. Capsule contents: white or almost white powder.
ALAMUT 10 mg + 10 mg hard capsules: Hard gelatin capsules with an opaque brown cap and an opaque white body. Capsule contents: white or almost white powder.

ALAMUT is available in blisters containing 28 capsules.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via Dei Castelli Romani, 22
00071 Pomezia (Roma), Italy

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