5 mg, 10 mg tablets 
amlodipine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.l.

In this leaflet you will find information about: 
1. What Amlodipine Aurobindo is and what it is used for 
2. What you need to know before taking Amlodipine Aurobindo 
3. How to take Amlodipine Aurobindo 
4. Possible side effects 
5. How to store Amlodipine Aurobindo 
6. Contents of the packaging and other information 

What Amlodipine Aurobindo is and what it is used for

Amlodipine Aurobindo contains the active substance amlodipine which belongs to a group of medicines called calcium channel blockers.

Amlodipine Aurobindo is used to treat high blood pressure ( hypertension ) or a special type of chest pain called angina. A rare form of this is Prinzmetal’s angina or variant angina.

In patients with high blood pressure, the drug reduces the resistance in the blood vessels, so that the blood can pass more easily. In patients with angina, Amlodipine Aurobindo works by increasing blood flow to the heart muscle, which then receives more oxygen. That way, chest pain is prevented. The drug does not provide immediate relief of chest pain in angina.

Amlodipine contained in Amlodipine Aurobindo may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Amlodipine Aurobindo

Do not take Amlodipine Aurobindo

  • if you are allergic (hypersensitive) to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium channel blocker. Symptoms may include 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 condition that means that the heart is unable to supply the body with sufficient amounts of blood).
  • if you have heart failure after a heart attack

Warnings and cautions

Talk to your doctor or pharmacist before taking Amlodipine Aurobindo. Tell your doctor if you have or have had any of the following conditions:

  • recent heart attack
  • heart failure
  • very high blood pressure (hypertensive crisis)
  • liver disease
  • if you are older and your dose needs to be increased

Children and young people

Amlodipine Aurobindo has not been studied in children under 6 years of age. Amlodipine Aurobindo should only be used to treat hypertension in children and adolescents between 6 and 17 years of age (see section 3).

For more information, talk to your doctor.

Other medicines and Amlodipine Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Amlodipine Aurobindo may affect or be affected by other medicines, such as:

  • ketoconazole, itraconazole ( antifungal )
  • ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV )
  • rifampicin, erythromycin, clarithromycin (antibiotic)
  • Hypericum perforatum ( St. John’s wort )
  • verapamil, diltiazem (heart medicine)
  • dantrolene ( infusion for severe body temperature disturbances).
  • tacrolimus (medicines used to change the way the immune system works)
  • simvastatin (a cholesterol-lowering drug)
  • ciclosporin (medicines that suppress the immune system)

Amlodipine Aurobindo may lower your blood pressure further if you are already taking other medicines for high blood pressure.

Use of Amlodipine Aurobindo with food and drink

If you are taking Amlodipine Aurobindo, do not eat grapefruit or drink grapefruit juice. Grapefruit and grapefruit juice can lead to an increase in the amount of the active substance amlodipine in the blood, which can lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Aurobindo.

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you are pregnant or planning to become pregnant, tell your doctor before taking Amlodipine Aurobindo.

Breast-feeding

Amlodipine passes into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, tell your doctor before taking Amlodipine Aurobindo.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amlodipine Aurobindo may affect your ability to drive or use machines. If you feel unwell, dizzy, or tired, or have headaches from the tablets, do not drive or use machines. Contact your doctor immediately.

You are responsible for assessing whether you are fit to drive a motor vehicle and/or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects or side effects. Descriptions of these effects and/or side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Amlodipine Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended starting dose is 5 mg Amlodipine Aurobindo once daily. Dose one can be increased to 10 mg Amlodipine Aurobindo once daily.

You can take the medicine before or after food or drink. You should take the medicine at the same time each day with a glass of water. Do not take Amlodipine Aurobindo with grapefruit juice.

Use for children and adolescents

The recommended starting dose for children and adolescents (6-17 years) is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Amlodipine 2.5 mg is currently not available and a 2.5 mg dose can not be obtained with the Amlodipine Aurobindo 5 mg tablet as these tablets are not manufactured in such a way that they can be divided into two equal parts.

It is important that you take the tablets at all times. Do not wait until the tablets run out before going to the doctor.

If you take too many tablets, your blood pressure may be low or even dangerously low. You may feel dizzy, unsteady, faint, or weak. If the blood pressure drops low enough, you can experience shock. The skin then feels cold and moist and you can become unconscious. Seek immediate care if you have taken too many Amlodipine Aurobindo tablets.

If you forget to use Amlodipine Aurobindo

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

If you stop using Amlodipine Aurobindo

Your doctor will tell you how long to take this medicine. Your illness may return if you stop taking the medicine earlier.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

See your doctor immediately if you get any of the following side effects after 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 that makes it very difficult to breathe
  • severe skin reactions such as severe rash, hives, redness all over the body, severe itching, blisters, skin flaking and swelling, inflamed mucous membranes ( Stevens-Johnson syndrome, toxic epidermal necrolysis ), or other allergic reactions
  • heart attack, abnormal heart rate ( pulse )
  • inflammation of the pancreas, which can cause severe abdominal and back pain and a strong feeling of illness.

The following very common side effects are reported. If any of these cause you problems or if they last for more than a weekconsult your doctor.

Very common side effects: may affect more than 1 user in 10

  • edema (swelling due to fluid)

The following common side effects are reported. If any of these cause you problems or if they last for more than a weekconsult your doctor.

Common side effects: may affect up to 1 in 10 people:

  • headache, dizziness, drowsiness (especially at the beginning of treatment)
  • palpitations (you feel the heartbeat), hot flashes
  • abdominal pain, nausea
  • altered bowel habits, diarrhea, constipation, indigestion
  • fatigue, weakness
  • visual disturbances, double vision
  • muscle cramps
  • swollen ankles ( edema ), fatigue.

Other side effects reported are listed below. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon side effects: may affect up to 1 in 100 people:

  • mood swings, anxiety, depression, insomnia
  • tremors, taste change, fainting, weakness
  • numbness or tingling in the arms and legs, inability to feel pain
  • earrings
  • low blood pressure
  • sneezing / runny nose due to inflammation of the nasal mucosa ( rhinitis )
  • cough
  • dry mouth, vomiting
  • hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
  • urination problems, increased need to urinate at night, increased urination frequency
  • impotence, discomfort from or enlarged breasts in men
  • pain, feeling sick
  • joint or muscle pain, back pain
  • weight gain or weight loss.

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

  • confusion

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

  • decreased number of white blood cells, decreased number of platelets that can lead to bruising or bleeding easily
  • elevated blood sugar (hyperglycemia)
  • a nerve disorder that can cause muscular weakness, tingling, or numbness
  • swollen gums
  • swollen abdomen ( gastritis )
  • abnormal liver function, inflammation of the liver ( hepatitis ), yellowing of the skin (jaundice), elevated liver enzymes that may affect certain medical tests
  • increased muscle tone (muscle tension)
  • inflammation of the blood vessels, often with a rash
  • photosensitivity
  • diseases that combine rigidity, tremor, and/or movement disorders

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via:

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

By reporting side effects, you can help increase drug safety information

5. How to store Amlodipine Aurobindo

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is amlodipine as amlodipine besylate.
  • The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

What the medicine looks like and the contents of the pack

Tablet

5 mg: white or almost white, flat, cylindrical tablet with beveled edges, marked with “C” on one side and “58” on the other side. The size is 7.9 mm x 5.6 mm.

10 mg: white or almost white, flat, round (9.5 mm in diameter) tablet with beveled edges, marked with “C” on one side and “59” on the other side.

PVC / polyvinylidene chloride-aluminum blister.

7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 120, 200, 250, 300 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Amlodipine Aurobindo tablets are approved in the European Economic Area under the names:
Germany Amlodipine Aurobindo 5 mg / 10 mg tablets
Spain Amlodipino Aurobindo 5 mg / 10 mg compresses EFG
Ireland Amlodipine Aurobindo 5 mg / 10 mg tablets
Italy Amlodipine Aurobindo 5 mg / 10 mg compress
Malta Amlodipine Aurobindo 5 mg / 10 mg Tablets
Poland Amlodipine Aurobindo
Portugal Amlodipine Aurobindo
Romania Amlodipine Aurobindo 5 mg / 10 mg compress
UK Amlodipine 5 mg / 10 mg tablets

Muhammad Nadeem

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