Amlodipine Mylan

Package leaflet: Information for the patient

Amlodipine Mylan 5 mg tablets, 10 mg tablets

amlodipine
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Amlodipine Mylan is and what it is used for

Amlodipine Mylan tablets contain amlodipine, which belongs to a group of medicines called calcium antagonists.
Amlodipine is used to treat high blood pressure (hypertension) or certain types of chest pain known as angina, including a rare form called Prinzmetal's angina or variant angina.
In patients with high blood pressure, your medicine works by relaxing the blood vessels, allowing blood to flow through them more easily. In patients with angina, amlodipine improves blood supply to the heart muscle, thereby increasing oxygen delivery and preventing chest pain.
Your medicine does not provide immediate relief from angina-related chest pain.
Talk to your doctor if you feel unwell or your condition worsens.

2. What you need to know before taking Amlodipine Mylan

Do not take Amlodipine Mylan

• If you are allergic to amlodipine or to any of the ingredients of this medicine (listed in section 6), or to any other calcium antagonist
• If you have severe low blood pressure (hypotension)
• If blood flow from the left side of the heart is obstructed (e.g. you have narrowing of the aortic heart valve (aortic stenosis))
• If you have heart failure following a heart attack
• If you have cardiogenic shock (a condition in which your heart is unable to supply enough blood to your body).

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Mylan if you have or have had any of the following conditions:

• Heart failure
• Severe high blood pressure (hypertensive crisis)
• Liver disease.

During treatment
Talk to your doctor:

• If you are elderly and your dose needs to be increased, as special care must be taken when increasing the dosage in elderly patients.

Children and adolescents
Amlodipine has not been studied in children under 6 years of age. Amlodipine should only be used for hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, talk to your doctor.
Other medicines and Amlodipine Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Amlodipine may affect or be affected by other medicines, such as:

• antifungal medicines (e.g. ketoconazole, itraconazole)
• so-called protease inhibitors used to treat HIV (e.g. ritonavir, indinavir, nelfinavir)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John’s wort)
• verapamil, diltiazem (medicines for the heart)
• dantrolene (infusion for serious body temperature disorders)
• simvastatin (a medicine used to reduce cholesterol levels in the blood)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the response of your immune system). Amlodipine may increase blood levels of these medicines.
• cyclosporine (if you have had a kidney transplant and are taking cyclosporine), since amlodipine may alter the amount of this medicine in your blood.

Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat high blood pressure.
Amlodipine Mylan with food and drink
Grapefruit and grapefruit juice must not be consumed by people taking amlodipine.
This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of amlodipine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of amlodipine during human pregnancy has not been established.
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or planning to breastfeed, you must inform your doctor before taking this medicine. Your doctor will advise you to take this medicine only if the benefits of treatment outweigh the risks to the baby.
Driving and using machines
Amlodipine may affect your ability to drive or use machinery. If the tablets cause you nausea, dizziness or tiredness, or give you headaches, do not drive or operate machinery. These side effects may occur especially at the beginning of treatment.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Amlodipine Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended starting dose is Amlodipine Mylan 5 mg once daily. The dose may be increased to Amlodipine Mylan 10 mg once daily.
Your medicine may be taken before or after food or drinks. Take your medicine at the same time each day with a glass of water.

Patients with liver problems
Your doctor may advise you to take a lower dose and carry out regular check-ups if you have liver problems.

Use in children and adolescents
For children and adolescents (6 to 17 years of age), the usual recommended starting dose is 2.5 mg daily.
The maximum recommended dose is 5 mg daily.
The tablet may be divided into two equal doses.

It is important to continue taking your tablets. Do not wait until your tablets are finished before seeing your doctor.

If you take more Amlodipine Mylan than you should
Taking too many tablets may cause your blood pressure to become low or dangerously low. You may experience dizziness, feel lightheaded, faint, feel weak, or have a rapid heartbeat. If the drop in blood pressure is severe enough, you may go into shock. Your skin may feel cold and clammy and you may lose consciousness. Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.
Seek immediate medical help if you take too many amlodipine tablets.

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

If you stop taking Amlodipine Mylan
Your doctor will advise you how long you should take your medicine. Your original condition may return if you stop taking your medicine before you are told to do so.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you notice any of the following side effects, stop taking this medicine and contact your doctor or go immediately to the nearest emergency room:

• Swelling of the eyelids, face, lips, tongue and throat which may cause severe breathing or swallowing difficulties.
• Severe skin reactions including severe rashes, hives, redness of the skin all over the body, severe itching, blistering, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack or abnormal or irregular heartbeat, rapid heart rate.
• Inflamed pancreas which may cause severe abdominal or back pain accompanied by a strong feeling of illness.
• Yellowing of the skin or eyes, pale stools, dark urine or stomach pain (these may be signs of liver problems such as inflammation of the liver (hepatitis) or jaundice).
• Difficulty speaking or swallowing, loss of balance control, mask-like facial expression, shuffling gait, stiffness of arms and legs, tremors or agitation of hands or fingers (extrapyramidal syndrome).

Other possible side effects:
Very common (may affect more than 1 in 10 people)

• Swelling due to fluid retention in tissues

Common (may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• Abdominal pain, nausea, changes in bowel habits including diarrhoea and constipation, indigestion
• Swollen ankles, fatigue, unusual weakness
• Visual disturbances including double vision
• Shortness of breath, muscle cramps

Uncommon (may affect up to 1 in 100 people)

• Mood changes (including feeling anxious), depression, insomnia
• Tremor, taste disturbances, fainting
• Tingling or numbness sensation in limbs; decreased sensitivity
• Ringing in the ears
• Slow heart rate
• Low blood pressure
• Sneezing or runny nose due to inflammation of nasal mucosa (rhinitis), cough
• Dry mouth, vomiting (nausea)
• Hair loss, increased sweating, skin itching, red blisters on the skin, skin discoloration, rash and hives, purple spots on the skin
• Urination difficulties, increased frequency of urination at night, more frequent urination
• Inability to achieve erection; discomfort or enlargement of breasts in men
• Pain, chest pain, malaise
• Joint or muscle pain, 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)

• Increased risk of infections or fever, e.g. sore throat, mouth ulcers developing (due to decreased white blood cell count), or if you notice unexplained bruising or bleeding (due to decreased platelet count in the blood)
• High blood sugar levels (hyperglycaemia)
• Nerve disorder which may cause weakness, numbness or tingling
• Swollen gums
• Bleeding gums (gingival bleeding)
• Abdominal swelling (gastritis)
• Increased liver enzymes which may be caused by liver disorders such as bile duct obstruction
• Measles-like skin rash. This may be associated with high fever and joint pains (erythema multiforme).
• Skin peeling over large areas of the body
• Inflammation of blood vessels, often with skin rash
• Skin sensitivity to light
• Concomitant disorders involving stiffness, tremor and/or movement disturbances

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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Mylan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle or blister pack
after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any discolouration of the tablets.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amlodipine Mylan contains

• The active substance is amlodipine.
• Each tablet contains 5 mg or 10 mg of amlodipine (as besylate).
• The other excipients are calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.

Description of the appearance of Amlodipine Mylan and pack contents
Amlodipine Mylan 5 mg tablets are white, round, biconvex, with "5" engraved on one side and a score line on the opposite side. The tablet can be divided into two equal parts.
Amlodipine Mylan 10 mg tablets are white, round, biconvex, with "10" engraved on one side and a score line on the opposite side. The tablet can be divided into two equal parts.
Amlodipine Mylan is packaged in blisters containing 10, 14, 28, 30, 50, 56, 60, 90, 100 and 180 tablets.
Amlodipine Mylan is also packaged in bottles containing 28, 30, 56, 100, 180 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer responsible for batch release
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
Viatris UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Amlodipine besilate Viatris 5 mg tabletten
Amlodipine besilate Viatris 10 mg tabletten
Czech Republic: Amlodipin Viatris 5 mg, tablety
Amlodipin Viatris 10 mg, tablety
Germany: Amlodipin dura B 5 mg Tabletten
Amlodipin dura B 10 mg Tabletten
Ireland: Amlodipine Viatris 5 mg tablets
Amlodipine Viatris 10 mg tablets
Italy: Amlodipina Mylan 5 mg compresse
Amlodipina Mylan 10 mg compresse
Poland: Amlomyl
Spain: Amlodipino Viatris 5 mg comprimidos EFG
Amlodipino Viatris 10 mg comprimidos EFG
Netherlands: Amlodipine (als besilaat) Viatris 5 mg tabletten
Amlodipine (als besilaat) Viatris 10 mg tabletten
United Kingdom: Amlodipine 5 mg tablets
Amlodipine 10 mg tablets