Amlodipine fair-med

Package leaflet: Information for the user

Amlodipine Fair-Med, 5 mg, tablets
Amlodipine Fair-Med, 10 mg, tablets
Amlodipine
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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Amlodipine Fair-Med is and what it is used for
Amlodipine Fair-Med contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Amlodipine Fair-Med is used to treat high blood pressure (hypertension) and angina pectoris – a type of chest pain, including the rare form known as vasospastic angina (Prinzmetal's angina).
In patients with high blood pressure, the medicine causes blood vessels to widen, allowing blood to flow through more easily. In patients with angina, Amlodipine Fair-Med works by improving blood flow to the heart muscle, delivering more oxygen and thereby preventing chest pain. However, Amlodipine Fair-Med does not immediately relieve chest pain in patients with angina.

2. Important information before taking Amlodipine Fair-Med

When not to take Amlodipine Fair-Med

• If you are allergic to the active substance of this medicine, to any other calcium channel blocker, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include itching, redness of the skin, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body).
• If you have heart failure following a heart attack.

Warnings and precautions
Before starting Amlodipine Fair-Med, discuss this with your doctor, pharmacist, or nurse.
Tell your doctor if you have or have had any of the following conditions:

• Recent heart attack.
• Heart failure.
• Severe high blood pressure (hypertensive crisis).
• Liver disease.
• Need for dose adjustment in elderly patients.

Children and adolescents
Studies on the use of Amlodipine Fair-Med in children under 6 years of age have not been conducted.
Amlodipine Fair-Med should only be used for the treatment of hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.
Amlodipine Fair-Med and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Amlodipine Fair-Med may affect other medicines, and other medicines may affect the action of this medicine. These include:

• ketoconazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's wort (Hypericum perforatum);
• verapamil, diltiazem (heart medicines);
• dantrolene (a medicine used intravenously in severe disturbances of body temperature);
• simvastatin (a medicine that lowers cholesterol levels).

Amlodipine Fair-Med may cause a greater reduction in blood pressure if you are already taking antihypertensive medicines.
Amlodipine Fair-Med with food and drink
Patients taking Amlodipine Fair-Med should not drink grapefruit juice or consume grapefruits. This is because grapefruits and grapefruit juice may increase the blood concentration of the active substance (amlodipine), which could lead to an unexpected intensification of the blood pressure-lowering effect of Amlodipine Fair-Med.
Pregnancy and breastfeeding
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 have a baby, consult your doctor or pharmacist before taking this medicine.
Breastfeeding
It is not known whether amlodipine passes into human milk. Women who are breastfeeding or intend to breastfeed should inform their doctor before taking Amlodipine Fair-Med.
Seek advice from your doctor or pharmacist before taking any medicine.
Driving and using machines
Amlodipine Fair-Med may affect your ability to drive or operate machinery.
If the tablets cause nausea, dizziness, tiredness, or headache, do not drive or operate machinery and contact your doctor immediately.

3. How to take Amlodipine Fair-Med

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose of Amlodipine Fair-Med is 5 mg once daily. The dose of Amlodipine Fair-Med
may be increased to 10 mg once daily.
This medicine may be taken before or after food (and drink). The medicine should be taken every day at the same time, with water. Do not take Amlodipine Fair-Med with grapefruit juice.
Use in children and adolescents
In children and adolescents (aged 6–17 years), the usual starting dose is 2.5 mg once daily.
The maximum recommended dose is 5 mg once daily.
In case a 2.5 mg dose (currently unavailable) is required, the patient should receive another product available on the market.
It is important to maintain continuous treatment. You should contact your doctor before finishing the medicine package.
Taking more Amlodipine Fair-Med than recommended
Taking too many tablets may cause significant and even dangerous lowering of blood pressure.
Symptoms may include dizziness, a feeling of "emptiness" in the head, fainting, or weakness.
In case of a severe drop in blood pressure, shock may occur. The patient's skin may become cold and clammy, and the patient may lose consciousness. If an overdose of Amlodipine Fair-Med is taken, contact your doctor immediately.
Missing a dose of Amlodipine Fair-Med
This is not dangerous. If a patient forgets to take a tablet, the missed dose should simply be skipped. The next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.
Stopping treatment with Amlodipine Fair-Med
Your doctor will inform you about the duration of treatment. Symptoms may return if the patient stops taking the medicine without consulting their doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following very rare, serious adverse reactions occur after taking this medicine:

• Sudden onset of wheezing, chest pain, shortness of breath, difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat causing significant breathing difficulties.
• Severe skin reactions, including widespread rash, urticaria and redness of the entire skin surface, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions.
• Myocardial infarction, irregular heartbeat.
• Pancreatitis which may cause severe abdominal and back pain accompanied by a very poor general condition.

The following common adverse reactions have been reported. If any of these symptoms are troublesome or persist for more than one week, you should contact your doctor.
Common adverse reactions: may occur in less than 1 in 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment).
• Palpitations (awareness of heartbeat), flushing.
• Abdominal pain, nausea.
• Swelling of the ankles, feeling of fatigue.

Other adverse reactions that have been reported are listed below. If any of the symptoms worsen or if you experience any adverse reactions not listed below, you should inform your doctor or pharmacist.
Uncommon adverse reactions: may occur in less than 1 in 100 patients

• Mood changes, anxiety, depression, insomnia.
• Tremor, taste disturbances, fainting, weakness.
• Numbness or tingling sensation in limbs; loss of pain sensation.
• Visual disturbances, double vision, tinnitus.
• Low blood pressure.
• Sneezing/rhinitis caused by inflammation of the nasal mucosa.
• Unusual gastrointestinal sensations, diarrhoea, constipation, indigestion, dry mouth, vomiting.
• Hair loss, increased sweating, skin itching, red skin spots, skin discoloration.
• Urinary disorders, increased need to urinate at night, more frequent urination.
• Erectile dysfunction, discomfort or enlargement of breast glands in men.
• Weakness, pain, malaise.
• Joint or muscle pain, muscle cramps, back pain.
• Increase or decrease in body weight.

Rare adverse reactions: may occur in less than 1 in 1,000 patients

• Disorientation.

Very rare adverse reactions: may occur in less than 1 in 10,000 patients

• Decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising or easy bleeding (destruction of red blood cells).
• Increased blood glucose levels (hyperglycaemia).
• Nerve disorders, which may cause weakness, tingling or numbness.
• Cough, gum swelling.
• Abdominal bloating (gastritis).
• Liver dysfunction, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect certain medical tests.
• Increased muscle tension.
• Vasculitis, often with skin rash.
• Photophobia (light sensitivity).
• Disorders characterized by stiffness, tremor and (or) movement disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Amlodipine Fair-Med

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Amlodipine Fair-Med contains

• The active substance is amlodipine besilate. Each tablet contains an amount of amlodipine besilate equivalent to 5 mg of amlodipine.
• The active substance is amlodipine besilate. Each tablet contains an amount of amlodipine besilate equivalent to 10 mg of amlodipine.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, and magnesium stearate.

What Amlodipine Fair-Med looks like and contents of the pack
5 mg tablets: white to almost white, round, uncoated, biconvex tablets, smooth on both sides.
10 mg tablets: white to almost white, round, uncoated, biconvex tablets, with a score line on one side and smooth on the other. The tablet can be divided into equal doses.
PVC/PVDC/Aluminium blister packs in cardboard boxes.
5 mg:
30 tablets
10 mg:
30 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PharmSol Europe Limited
Victoria Centre Unit 2
Lower Ground Floor Valletta Road
Mosta, MST 9012 Malta

Manufacturer/Importer
Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany
Fine Foods Pharmaceuticals N.M.T. S.p.A.
Via Berlino, 39
24040 Zingonia-Verdellino, BG, Italy

This medicinal product is authorised in the European Economic Area under the following names:
Portugal: Amlodipina Fair-Med
Austria: Amlodipin Fair-Med 5mg, 10mg Tabletten
Germany: Amlodipin Fair-Med Healthcare 5mg, 10mg Tabletten
Spain: Amlodipino Fair-Med 5mg, 10mg Comprimidos EFG
Ireland: Amlodipine Fair-Med 5mg, 10mg Tablets
Italy: Amlodipina Fair-Med
Poland: Amlodipine Fair-Med