Ammorro: detailed information

Package leaflet: Information for the user

Ammorro, 5 mg+1.5 mg, modified-release hard capsules
Ammorro, 10 mg+1.5 mg, modified-release hard capsules
Ramipril + Indapamide
Please read all of 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Ammorro is and what it is used for
What you need to know before taking Ammorro
How to take Ammorro
Possible side effects
How to store Ammorro
Contents of the pack and other information

1. What Ammorro is and what it is used for

Ammorro modified-release hard capsules may be used for the treatment of
hypertension (high blood pressure) in adult patients.
Ammorro contains two different active substances, ramipril and indapamide, in one
capsule. Both substances help control high blood pressure:

Ramipril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works by reducing the production of a substance that may increase blood pressure. The medicine causes blood vessels to relax and widen, making it easier for the heart to pump blood around the body.
Indapamide is a diuretic. Most diuretics increase the volume of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine volume. In addition, indapamide widens blood vessels, which helps improve blood flow. This helps lower blood pressure.

Your doctor may prescribe Ammorro in the form of modified-release hard capsules
containing a fixed dose if you are already taking ramipril and indapamide at the same dose
but as separate products.

2. Important information before taking Ammorro

When not to take Ammorro

if the patient is allergic to ramipril, any other ACE inhibitor, indapamide, or other sulfonamides, or to any of the other ingredients of this medicine (listed in section 6).
if the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and mouth, difficulty breathing and swallowing.
if the patient has recently taken or is currently taking sacubitril+valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, e.g. in the throat area).
if the patient is undergoing dialysis or another type of blood filtration. Depending on the device used, Ammorro may be unsuitable for such patients.
if the patient has severe kidney disease, or other kidney diseases associated with reduced blood flow to the kidneys (renal artery stenosis).
if the patient has severe liver disease or a condition called hepatic encephalopathy (brain dysfunction caused by liver disease).
if the patient has low potassium levels in the blood.
if the patient is more than 3 months pregnant (Ammorro is also not recommended during early pregnancy - see section 'Pregnancy and breastfeeding').
if the patient's blood pressure is abnormally low or unstable. The doctor will need to perform an appropriate assessment.
if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Ammorro if any of the above situations apply. In case of
doubt, consult your doctor before starting Ammorro.
Warnings and precautions
Before starting Ammorro, discuss this with your doctor or pharmacist.

if the patient has liver diseases (e.g. cirrhosis or ascites);
if the patient has diabetes;
if the patient has gout;
if the patient has heart problems, including any heart rhythm disorders;
if the patient has kidney problems (including kidney transplant) or is undergoing dialysis;
if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Ammorro. Without treatment, these symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
if the patient has lost a significant amount of salt or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics, or dialysis);
if the patient is planning treatment to reduce the effects of allergy to bee or wasp venom (desensitization therapy);
if the patient is to receive anaesthesia for surgery or dental procedures. It may be necessary to stop taking the medicine one day before anaesthesia; consult your doctor;
the doctor may order blood tests if the patient has high or low levels of potassium and sodium, or high calcium levels (visible in blood test results);
if the patient is taking medicines or has diseases that may reduce sodium levels in the blood. In such cases, the doctor may recommend regular blood tests, especially to monitor blood sodium levels, particularly in elderly patients;
if the patient is taking any of the following medicines, the risk of angioedema or severe allergic reaction may be increased:
o neprilysin inhibitors (NEP) (such as racecadotril, a medicine used to treat diarrhoea);
o medicines used to prevent rejection of transplanted organs or to treat cancer (e.g. temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors);
o vildagliptin, a medicine used to treat diabetes.
See also sacubitril and valsartan, section 2 "When not to take Ammorro";
if the patient has collagen vascular disease (connective tissue disease), such as systemic lupus erythematosus or systemic sclerosis;
if the patient is taking any of the following medicines for high blood pressure:
o angiotensin II receptor antagonists (ARBs) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if the patient has kidney disease related to diabetes;
o aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels
(e.g. potassium, sodium, calcium) in blood.
See also information under the heading “When not to take Ammorro”;

if the patient has muscle disorders, including muscle pain, tenderness, weakness, or cramps;
if the patient is scheduled for a test assessing parathyroid function;
inform the doctor if the patient thinks she is pregnant (or might become pregnant). Ammorro is not recommended during the first 3 months of pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period (see section "Pregnancy and breastfeeding");
inform the doctor if the patient is photosensitive (sensitive to sunlight).

ACE inhibitors cause angioedema (an allergic reaction
that may include rash, difficulty swallowing or breathing, swelling of lips, face,
throat or tongue) more frequently in black patients than in patients of other races.
Like other ACE inhibitors, ramipril may be less effective in lowering blood pressure in
black patients than in patients of other races.
If the patient thinks any of the described situations may apply, or has any questions
or doubts about taking Ammorro, they should consult their doctor or pharmacist.
Children and adolescents
Ammorro is not recommended for use in children and adolescents under 18 years of age, as
safety and efficacy have not been established in this patient group.
Ammorro with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, and any medicines the patient plans to take. This is important because Ammorro
may affect the action of certain other medicines. Likewise, other medicines may affect the action
of Ammorro.
The doctor may recommend changing the dose, taking other precautions, or even discontinuing one of the following medicines.
Do not take Ammorro with lithium (used, among others, in treating depression) due to the risk of increased lithium levels in the blood.
If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “When not to take Ammorro” and “Warnings and precautions”).
Ensure that the doctor is informed about the use of the following
medicines:

Sacubitril and valsartan, used to treat certain types of chronic (long-term) heart failure in adults (see section 2 “When not to take Ammorro”);
Angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure);
Medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium, procainamide);
Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergy, such as isoprenaline, dobutamine, noradrenaline, adrenaline, ephedrine, dopamine. The doctor will need to monitor blood pressure;
Medicines used to treat angina (chest pain), such as nitrates, bepridil;
Medicines used to treat benign prostatic hyperplasia (e.g. alfuzosin, doxazosin, prazosin, tamsulosin, terazosin);
Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid);
Medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics such as chlorpromazine, levomepromazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol, pimozide) or for treating addiction (methadone);
Vinpocetine administered by injection (used for symptomatic treatment of cognitive disorders in elderly patients, including memory loss);
Antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, erythromycin administered by injection);
Pentamidine (used to treat certain types of pneumonia);
Amphotericin B administered by injection (antifungal medicines);
Halofantrine (an antiparasitic medicine used to treat certain types of malaria);
Antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, astemizole, terfenadine);
Medicines used to treat cancer (chemotherapy), e.g. temsirolimus;
Medicines used to prevent transplant rejection (e.g. cyclosporine, tacrolimus, sirolimus, everolimus and other mTOR inhibitors) or to treat autoimmune diseases, severe rheumatic or dermatological conditions;
Diuretics (water pills), such as furosemide;
Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in blood (e.g. spironolactone, triamterene, amiloride, trimethoprim alone or in combination with sulfamethoxazole (co-trimoxazole, used to treat bacterial infections), and heparin (a blood thinner));
Steroid medicines used to treat various diseases, including severe asthma and inflammatory conditions, such as prednisolone;
Allopurinol (used to lower uric acid levels in blood);
Racecadotril (used to treat diarrhoea);
Iodinated contrast agents (used in X-ray examinations);
Calcium tablets or other calcium supplements;
Cisapride, difenhydramine (used to treat gastrointestinal problems);
Stimulant laxatives;
Tetracosactide (used to treat Crohn's disease);
Baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
Medicines for diabetes, such as oral glucose-lowering agents (e.g. vildagliptin used to treat type 2 diabetes or metformin) and insulin. Ammorro may lower blood glucose levels. Blood sugar levels should be closely monitored during treatment with Ammorro.

If any of the above situations apply (or if the patient is unsure), consult your doctor before
taking Ammorro.
Taking Ammorro with food, drink and alcohol
Drinking alcohol while being treated with Ammorro may cause dizziness. If the patient has
doubts about how much alcohol they can consume while taking this medicine, they should talk to
their doctor, as blood pressure-lowering medicines and alcohol may mutually enhance their sedative effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have
a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
If the patient thinks she is pregnant (or might become pregnant), she must inform her doctor.
The doctor will advise stopping treatment with Ammorro before conception or immediately after
pregnancy is confirmed, and will recommend an alternative medicine. Ammorro should not be
used during the first 12 weeks of pregnancy, and must not be used after the 13th week
of pregnancy, as its use during pregnancy may harm the unborn child.
If the patient becomes pregnant while taking Ammorro, she should inform her doctor immediately. Treatment should be changed to another suitable medicine before planning a pregnancy.
Breastfeeding
Ammorro is not recommended for breastfeeding women. The doctor may recommend alternative
treatment if the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely.
Fertility
There are no data on the effect of Ammorro on fertility in humans.
There are no data on ramipril or indapamide used as monotherapy in humans.
Driving and operating machinery
Ammorro may cause adverse effects related to lowering of blood pressure,
such as dizziness or fatigue (see section 4). These adverse effects occur more
frequently at the beginning of treatment and after dose increases. In such cases, patients should refrain from
driving or performing other activities requiring concentration. However, these symptoms
are rare if treatment is well controlled.
Ammorro contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Ammorro

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Treatment of arterial hypertension is usually long-term.
The recommended dose is

One capsule (of the stated strength) taken at the same time each day, preferably in the morning.
Do not take more than one capsule per day.
This medicine is for oral use. The capsule should be swallowed whole, with an adequate amount of fluid, without chewing. When swallowing the capsule, slightly tilt the head forward.
Ammorro may be taken with or without food.

Use in children and adolescents
Ammorro is not recommended for use in children and adolescents under 18 years of age.
If you take more Ammorro than recommended
If a patient takes more capsules than prescribed, seek immediate medical advice from a doctor
or go to the nearest hospital emergency department. The patient should not drive; ask someone
else to take you to the hospital or call an ambulance.
Bring the medicine package with you. This will help the doctor identify which medicine has been taken.
The most likely symptom of overdose is low blood pressure. Symptoms of high blood pressure include nausea, vomiting, seizures, dizziness, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.
If you forget to take Ammorro
If a dose of Ammorro is missed, take the next dose at the usual time. Do not take a double dose to
make up for the missed dose.
Stopping Ammorro
Do not stop taking Ammorro suddenly or change the dose without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You must stop taking Ammorro and contact your doctor immediately if any of the following adverse
effects occur – urgent medical attention may be required:

Swelling of the face, lips, mouth, tongue or throat; swelling of the mucous membranes of the throat or airways, causing breathlessness or difficulty swallowing. This may be a sign of a severe allergic reaction (angioedema) to Ammorro. In such a case, contact your doctor immediately. (Not common) (may affect up to 1 in 100 people).
Severe skin reactions, including severe skin rash, mouth ulcers, worsening of pre-existing skin disease, redness, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), or other allergic reactions (e.g. urticaria). If such a situation occurs, contact your doctor immediately. (Very rare) (may affect up to 1 in 10,000 people).

You must tell your doctor immediately if you experience:

Faster, irregular or forceful heartbeat (in some cases life-threatening), chest pain, feeling of pressure in the chest, or more serious problems such as myocardial infarction and stroke may occur (frequency unknown).
Shortness of breath or cough. These may be symptoms of lung disease.
Easy bruising, longer than usual bleeding, various types of bleeding (e.g. bleeding gums), purple spots, skin changes or more frequent than usual infections, sore throat and fever, feeling of fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders.
Severe abdominal pain which may radiate to the back. This may be a sign of pancreatitis (Very rare: may affect up to 1 in 10,000 people).
Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disease, such as hepatitis or liver damage (hepatic encephalopathy may occur with unknown frequency).
Concentrated urine (dark in colour), nausea or vomiting, muscle cramps, confusion and seizures, which may result from inadequate vasopressin (antidiuretic hormone) secretion. If a patient experiences such symptoms, contact a doctor as soon as possible (frequency unknown).
Muscle weakness, cramps, tenderness or pain, particularly if the patient also feels unwell or has a high temperature, may be caused by abnormal muscle breakdown, known as rhabdomyolysis (may occur with unknown frequency).

Other adverse effects:
Common (may occur in up to 1 in 10 people)

Allergic (hypersensitivity) reactions, mainly affecting the skin, in people prone to allergies and asthmatic reactions;
Blood test results indicating increased or decreased potassium levels in the blood;
Dizziness, headache, more likely at the beginning of treatment with Ammorro or at the beginning of treatment with a higher dose;
Fainting, hypotension (abnormally low blood pressure, especially when standing up or sitting up quickly from a lying position, known as orthostatic hypotension);
Dry, irritating cough, sinusitis or bronchitis (inflammation of the airways), breathlessness (dyspnoea);
Stomach or intestinal pain or discomfort (inflammation), indigestion (bloating, heartburn), nausea or vomiting, diarrhoea;
Skin rash, especially maculopapular, with or without raised areas;
Chest pain;
Muscle cramps or pain;
Feeling of fatigue.

Uncommon (may occur in up to 1 in 100 people)

Increased number of eosinophils (a type of white blood cell) in the blood, shown in blood tests;
Loss or reduced appetite (anorexia);
Low sodium levels in the blood, which may lead to dehydration and low blood pressure (hyponatremia);
Low mood, feeling depressed, anxiety, increased nervousness or restlessness;
Sleep problems;
Sensation of spinning (vertigo);
Red dots on the skin (petechiae), itching and unusual skin sensations such as numbness, tingling, pricking, burning or skin numbness (paresthesia);
Loss or change in taste sensation;
Eye problems, including blurred vision, visual disturbances;
Pressure or pain in the chest, usually on the left side of the body, which may be a sign of myocardial infarction (e.g. angina or heart attack), faster, irregular or forceful heartbeat, palpitations (awareness of heartbeat), and swelling of the hands and feet, which may indicate the body retaining more fluid than usual (peripheral oedema);
Hot flushes;
Breathing difficulties or worsening of asthma, nasal congestion;
Severe allergic reaction (angioedema) manifesting as swelling of the skin of the limbs or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways, causing breathlessness or difficulty swallowing;
Intestinal swelling, called "intestinal angioedema", manifesting as upper abdominal pain, inflammation of the intestine (inflammation of the gastric mucosa), constipation and dry mouth;
Blood tests showing abnormal liver function (changes in liver enzyme activity, elevated bilirubin levels);
Severe abdominal pain which may radiate to the back, accompanied by increased pancreatic enzyme activity. This may be a sign of pancreatitis;
Impaired kidney function (including kidney failure), increased urine output during the day, worsening of pre-existing proteinuria, elevated blood urea and creatinine levels;
Excessive sweating;
Joint pain;
Impotence in men, decreased libido in men and women;
Fever.

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

Blood test results indicating reduced number of red blood cells (anaemia), white blood cells (neutropenia or agranulocytosis [which may cause unexplained fever, sore throat or other flu-like symptoms]), or platelets (leading to easy bruising and nosebleeds), or haemoglobin levels.
Low levels of chloride and magnesium in the blood.
Feeling of trembling (tremor) or disorientation (confusion).
Impaired balance.
Redness, itching, swelling or watering of the eyes (conjunctivitis).
Hearing disturbances or ringing in the ears.
Vasoconstriction, reduced blood flow through vessels (hypoperfusion), vasculitis.
Redness and swelling of the tongue.
Severe peeling or shedding of the skin, itchy papular skin lesions.
Urticaria.
Nail disorders (e.g. loosening or separation of the nail plate from the nail bed).
Development of skin spots and cold extremities.
Fatigue or weakness.

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

High calcium levels in the blood.
Increased sensitivity to light (photosensitivity reaction).
Severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin disease, redness, blistering or peeling of the epidermis, mucosal inflammation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), or other allergic reactions (e.g. urticaria).

Frequency not known (cannot be estimated from available data):

Blood tests showing too few blood cells (bone marrow not functioning properly).
Anaphylactic or anaphylactoid reactions, increased titres of antinuclear antibodies.
Difficulty concentrating, attention disorders.
Cerebral ischaemia, including ischaemic stroke and transient ischaemic attack.
Psychomotor disturbances, burning sensation, parosmia (altered sense of smell).
Myopia.
Worsening of vision or eye pain due to high pressure (possible signs of fluid accumulation in the choroid layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Abnormal ECG findings (prolonged QT interval), a specific type of arrhythmia called torsade de pointes (potentially fatal).
Colour change in fingers and toes in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon).
Mouth ulcers (aphthous stomatitis).
Exacerbation of psoriasis, psoriasiform dermatitis, bullous or lichenoid rash, mucosal rash, pemphigus.
Hair loss (alopecia).
In patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen.
Breast enlargement in men.
Increased blood glucose levels.
Increased blood uric acid levels, which may cause or exacerbate gout (joint pain, especially in the feet).
Muscle weakness, cramps, tenderness or pain, particularly when the patient also feels unwell or has a high temperature, may be caused by abnormal muscle breakdown, known as rhabdomyolysis.

Reported adverse effects of Ammorro were consistent with the adverse effect profiles of the individual active substances of Ammorro (ramipril and indapamide) administered at the same dose.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ammorro

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ammorro contains
The active substances are ramipril and indapamide.
Ammorro 5 mg + 1.5 mg, modified-release hard capsules
Each capsule contains 5 mg of ramipril and 1.5 mg of indapamide.
Ammorro 10 mg + 1.5 mg, modified-release hard capsules
Each capsule contains 10 mg of ramipril and 1.5 mg of indapamide.
The other ingredients are:
Capsule contents: monohydrate lactose, microcrystalline cellulose, crospovidone type B,
hypromellose, magnesium stearate, sodium stearyl fumarate, colloidal anhydrous silica,
colloidal hydrophobic silica, yellow iron oxide (E172).
Capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171).

What Ammorro looks like and contents of the pack
Ammorro 5 mg + 1.5 mg, modified-release hard capsules:
A hard, self-closing gelatin capsule, unmarked, size 0, with a light yellow body and a red cap, containing two tablets. The capsule is approximately 21.7 mm long. One tablet, containing ramipril, is a round, biconvex tablet in light yellow colour, without any markings; white and yellowish-brown specks may appear on the tablet surface. The second tablet, containing indapamide, is a round, biconvex tablet in white or yellowish-white colour, marked with "I" on one side and unmarked on the other.

Ammorro 10 mg + 1.5 mg, modified-release hard capsules:
A hard, self-closing gelatin capsule, unmarked, size 0, with a light yellow body and a reddish-brown cap, containing two tablets. The capsule is approximately 21.7 mm long. One tablet, containing ramipril, is a round, biconvex tablet in light yellow colour, without any markings; white and yellowish-brown specks may appear on the tablet surface. The second tablet, containing indapamide, is a round, biconvex tablet in white or yellowish-white colour, marked with "I" on one side and unmarked on the other.

Pack type and pack contents
10, 28, 30, 56, 60, 90, 100 or 112 modified-release hard capsules in blisters made of OPA/Aluminium/PVC/Aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend,
Hungary
Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest,
Hungary

This medicinal product is authorised in the European Economic Area under the following names:
Hungary Ammorro 5 mg/1.5 mg, 10 mg/1.5 mg modified-release hard capsules
Bulgaria Ramikomb 5 mg/1.5 mg, 10 mg/1.5 mg hard capsules with modified release
Ramikomb 5 mg/1.5 mg, 10 mg/1.5 mg modified-release hard capsules
Czech Republic Bontens
Lithuania Camimbo 5 mg/1.5 mg, 10 mg/1.5 mg modified-release hard capsules
Latvia Camimbo 5 mg/1.5 mg, 10 mg/1.5 mg modified-release hard capsules
Poland Ammorro
Romania Ramikomb 5 mg/1.5 mg, 10 mg/1.5 mg modified-release capsules
Slovakia Camimbo 5 mg/1.5 mg, 10 mg/1.5 mg

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00