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.

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

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

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

Amlodipine Sandoz is used for treating:

  • high blood pressure ( hypertension )
  • 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 Sandoz 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 Sandoz 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

What you need to know before you take Amlodipine Sandoz

Do not take Amlodipine Sandoz

  • if you are allergic to amlodipine, any other calcium channel blockers, or any of the other ingredients of this medicine (listed in section 6). 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 if you have or have had any of the following:

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

For more information, talk to your doctor.

Other medicines and Amlodipine Sandoz

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 Sandoz can 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 )
  • Hypericum perforatum ( St. John’s wort )
  • verapamil, diltiazem (heart medicine)
  • dantrolene ( infusion for severe disorders of body temperature)
  • simvastatin (treatment of high blood cholesterol levels)
  • tacrolimus, ciclosporin (used to control the body’s immune response, allows the body to accept the transplanted organ)

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

Amlodipine Sandoz with food and drink

If you are taking Amlodipine Sandoz, 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 Sandoz.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine in human pregnancy has not been established. 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.

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 Amlodipine Sandoz.

Driving and using machines

Amlodipine Sandoz 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.

Amlodipine Sandoz contains sodium

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

How to take Amlodipine Sandoz

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

The usual starting dose is 5 mg Amlodipine Sandoz once a day. Dose one can be increased to 10 mg Amlodipine Sandoz 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 Sandoz 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.

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

The tablet can be divided into two equal doses.

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 may experience shock. The skin then feels cold and moist and you can become unconscious. Seek immediate care if you have taken too many Amlodipine Sandoz tablets.

If you forget to take Amlodipine Sandoz

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 taking Amlodipine Sandoz

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 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 this causes you problems or if it lasts for more than a week, contact your doctor.

Very common (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 (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
  • swollen ankles
  • fatigue, weakness
  • visual disturbances, double vision
  • muscle cramps.

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
  • 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 unusual bruising or that you bleed easily
  • 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.

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 Amlodipine Sandoz

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 and blister or on the can after EXP. or EXP. The expiration date is the last day of the specified month.

Blister pack: Store in the original package. Sensitive to light. Do not store above 30 ° C.

HDPE jar: 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. Each tablet contains 5 mg or 10 mg of amlodipine (as belated).
  • The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (type A), and magnesium stearate.

What the medicine looks like and the contents of the pack

5 mg tablets

White or almost white, oblong tablet with beveled edges, notched on one side and marked “5” on the other side.

10 mg tablets

White or almost white, oblong tablet with beveled edges, notched on one side and marked “10” on the other side.

The tablets are packaged in Alu / PVC blister or in Alu / OPA / Alu / PVC blister and stored in a carton or packaged in an HDPE jar with a screw cap (safety seal).

Pack sizes:

Blister (Alu / PVC) / Blister (Alu / OPA / Alu / PVC): 10, 14, 20, 28, 30, 50, 50×1, 60, 100 and 120 tablets.

HDPE can: 20, 30, 50, 60, 90, 100, 105, 120, 200 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer:

LEK SA Ul. Podlipie 16 95-010 Stryków, Poland

or

LEK SA, ul. Domaniewska 50 C, PL-02-672 Warsaw, Poland

or

ROWA Pharmaceuticals Ltd., Bantry, Co. Cork, Ireland

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany

or

Lek Pharmaceuticals dd, Verovskóva 57, 1526 Ljubljana, Slovenia

or

Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia

or

SC Sandoz SRL, Str. Livezey no. 7A, 540472 Targu-Mures, Romania

Muhammad Nadeem

Leave a Reply