5 mg or 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.

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

1. What Amlodistad is and what it is used for

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

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

2. What you need to know before using Amlodistad

Do not use Amlodistad

  • If you are allergic to amlodipine or 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 in which 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 Amlodistad.

You should tell your doctor if you have or have had any of the following conditions:

  • Recent heart attacks.
  • 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 has not been studied in children under 6 years of age. Amlodistad 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 Amlodistad

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Amlodistad 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 ( antibiotics – for infection caused by bacteria)
  • Hypericum perforatum
  • verapamil, diltiazem (heart medicine)
  • dantrolene ( infusion for severe body temperature disturbances)
  • simvastatin (a cholesterol-lowering drug)
  • tacrolimus (used to control the body’s immune response, allows the body to accept the transplanted organ)
  • ciclosporin (a medicine that suppresses the immune system).

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

Amlodistad with food, drinks, and alcohol

If you are taking Amlodistad, 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 Amlodistad’s blood pressure-lowering effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The safety of amlodipine during pregnancy has not been established.

Breast-feeding

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

Driving and using machines

Amlodistad 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 or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and 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.

Amlodistad contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Amlodistad

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

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

Amlodistad 10 mg tablet can be divided into two equal doses.

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 Amlodistad 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.

Amlodistad 2.5 mg is currently not available and a dose of 2.5 mg cannot be obtained with Amlodistad 5 mg tablets as these tablets are not made to 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 use too much Amlodistad 

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 Amlodistad tablets.

If you forget to use Amlodistad

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 Amlodistad

Your doctor will tell you how long to take the 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 serious 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, blistering, 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 have been reported. If these cause you problems or if they last for more than a week, contact your doctor.

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

  • edema (swelling due to fluid).
  • The following common side effects have been reported. If these cause you problems or if they last for more than a week, contact your doctor.

Common (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.
  • 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 (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 (may affect up to 1 in 1,000 people):

  • confusion.

Very rare (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 (damage to red blood cells )
  • elevated blood sugar (hyperglycemia)
  • a nerve disorder that can cause muscle 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
  • disorders consisting of rigidity (stiffness), tremor (tremors), and / or movement disorders.

Has been reported (occurs in an unknown number of users):

  • tremors, stiff posture, worm-like face, slow movements, and sluggish, unbalanced gait.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Amlodistad

Keep out of sight and reach of children.

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.

Store in the original package. Sensitive to light.

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 besylate)

Amlodistad 5 mg tablets

  • Each tablet contains 5 mg of amlodipine (as amlodipine besylate).
  • The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium starch glycolate (Type A), magnesium stearate (E470b)

Amlodistad 10 mg tablets

  • Each tablet contains 10 mg of amlodipine (as amlodipine besylate).
  • The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium starch glycolate (Type A), magnesium stearate (E470b)

What the medicine looks like and the contents of the pack

Amlodistad 5 mg tablets

Amlodistad 5 mg are white, round tablets.

Amlodistad 10 mg tablets

Amlodistad10 mg are white round tablets with a scoreline on one side. The tablet can be divided into two equal doses.

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100 or 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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