AMLODIPINE FAIR-MED 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine Fair-Med 5 mg Tablets EFG

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

Contents of the pack:

1. What is Amlodipine Fair-Med and what is it used for
2. What you need to know before you take Amlodipine Fair-Med
3. How to take Amlodipine Fair-Med
4. Possible side effects
5. Storage of Amlodipine Fair-Med
6. Contents of the pack and other information

1. What is Amlodipine Fair-Med and what is it used for

Amlodipine Fair-Med contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Amlodipine Fair-Med is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare type called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine Fair-Med improves blood supply to the heart muscle, which receives more oxygen and as a result, chest pain is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. What you need to know before you take Amlodipine Fair-Med

Do not take Amlodipine Fair-Med

• If you are allergic to the active substance, to any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, redness of the skin, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Amlodipine Fair-Med. You should inform your doctor if you have or have had any of the following diseases:

• Recent heart attack
• Heart failure
• Sudden severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are an elderly person and your dose needs to be increased

Use in children and adolescents

Amlodipine Fair-Med has not been studied in children under 6 years old. Amlodipine Fair-Med should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old. (See section 3).

For more information, consult your doctor.

Use of other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

Amlodipine Fair-Med may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature abnormalities)
• simvastatin (cholesterol medicine)

If you are already taking other medicines for high blood pressure, Amlodipine Fair-Med may lower your blood pressure even further.

Taking Amlodipine Fair-Med with food and drinks

People taking Amlodipine Fair-Med should not consume grapefruit or grapefruit juice.

This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine Fair-Med.

Pregnancy, breastfeeding, and fertility

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, you should inform your doctor or pharmacist before taking Amlodipine Fair-Med.

Breastfeeding

It is unknown whether amlodipine passes into breast milk. If you are breastfeeding or about to start breastfeeding, you should inform your doctor before taking Amlodipine Fair-Med.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Fair-Med may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, or tired, or cause you headaches, do not drive or use machinery and consult your doctor immediately.

3. How to take Amlodipine Fair-Med

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The usual initial dose is 5 mg of Amlodipine Fair-Med, once a day. The dose can be increased to 10 mg of Amlodipine Fair-Med, once a day.

You can take your medicine before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Amlodipine Fair-Med with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years old), the recommended initial dose is 2.5 mg per day. The maximum recommended dose is 5 mg per day.

For the 2.5 mg dose (not available at this time), the patient should take any other available medication on the market.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished to go to your doctor.

If you take more Amlodipine Fair-Med than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty, and you could lose consciousness. If you take too many Amlodipine Fair-Med tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine Fair-Med

Do not worry. If you forget to take a tablet, do not take that dose. Take the next dose at the correct time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amlodipine Fair-Med

Your doctor will tell you for how long you should take this medicine. Your illness may come back if you stop taking this medicine before your doctor tells you to.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine Fair-Med can cause side effects, although not everybody gets them.

Go to your doctor immediately if you experience any of the following serious side effects, which are very rare when taking this medicine.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat, which can cause great difficulty breathing
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis, which can cause severe abdominal pain and back pain, accompanied by a great feeling of discomfort

The following common side effectshave been reported. If any of these cause problems or last more than a week, consult your doctor.

Common:may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Swelling of the ankles (edema), tiredness

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Uncommon:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased number of times you need to urinate
• Impotence, discomfort or enlargement of the breasts in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or weight loss

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

• Confusion

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

• Decrease in the number of white blood cells, decrease in blood platelets, which can cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause weakness, tingling, or numbness
• Cough, gum inflammation
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can affect some medical tests
• Increased muscle tension
• Inflammation of the blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

Reporting of side effects:

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Fair-Med

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 carton after {CAD}. The expiry date is the last day of the month stated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicinal products. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Fair-Med

• The active substance is amlodipine (as besylate). Each tablet contains amlodipine besylate equivalent to 5 mg of amlodipine.
• The other ingredients are: Microcrystalline Cellulose, Sodium Starch Glycolate (from potato), Colloidal Anhydrous Silica, and Magnesium Stearate.

Appearance of the product and contents of the pack

Amlodipine Fair-Med 5 mg tablets: uncoated, round, biconvex tablets, smooth on both sides, and white or almost white in color.

Amlodipine Fair-Med 5 mg tablets are packaged in white opaque PVC/PVdC-Alu blisters in boxes containing 20, 28, 30, 50, 60, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

Fairmed Healthcare GmbH

Dorotheenstr. 48, 22301 Hamburg, Germany

pv@fair-med.com

Manufacturer

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

Fine Foods & Pharmaceuticals N.M.T. S.p.A

Via R. Follereau, 25, 24027 Nembro, BG, Italy

This medicine is authorised in the Member States of the European Economic Area under the following names:

Portugal Amlodipine Fair-Med

Austria Amlodipin Fair-Med 5mg Tablets

Germany Amlodipin Fair-Med Healthcare 5mg Tablets

Spain Amlodipine Fair-Med 5mg Tablets EFG

Ireland Amlodipine Fair-Med 5mg Tablets

Italy Amlodipine Fair-Med

Malta Amlodipine Fair-Med 5mg Tablets

Poland Amlodipine Fair-Med

Date of last revision of this leaflet:November 2013