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AMLODIPIN MEDOCHEMIE TBL 10MG N30

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
AMLODIPIN-drug/medicine -tablets aproximate price on "AMLODIPIN MEDOCHEMIE TBL 10MG N30 " in Riga city, Latvia is:
  • 3.66€  3.96$  3.14£  423Rub  42.1SEK  16PLN  14.49₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  AMLODIPIN MEDOCHEMIE TBL 10MG N30     Recheck

ATC codeC08CA01 

Active substances: Amlodipinum

 


Vendor, principal: Medochemie Ltd
AMLODIPIN MEDOCHEMIE TBL 10MG N30 is compensated medicine in Latvia. 

 Prescription drug (℞) 

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 .

AMLODIPIN-RATIOPHARM 10MG N30

Package leaflet: Information for the user

Amlodipin-ratiopharm 5 mg, Tablets Amlodipin-ratiopharm 10 mg, Tablets

Amlodipine

Read all of this leaflet carefully before you start 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 or pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Amlodipin-ratiopharm is and what it is used for

Amlodipin-ratiopharm contain the active substance amlodipine which belongs to a group of medicines called calcium antagonists.
Amlodipin-ratiopharm are used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.
In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipin-ratiopharm work by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina.

2. What you need to know before you take Amlodipin-ratiopharm Do not take Amlodipin-ratiopharm:

-   If you are allergic to amlodipine, or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing
-   If you have severe low blood pressure (hypotension)
-   If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body)
-   If you suffer from heart failure after a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipin-ratiopharm.
You should inform your doctor if you have or have had any of the following conditions:
-   Recent heart attack
-   Heart failure
-   Severe increase in blood pressure (Hypertensive crisis)
-   Liver disease
-   You are elderly and your dose needs to be increased.

Children and adolescents

Amlodipine has not been studied in children under the age of 6 years. Amlodipin-ratiopharm should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3).
For more information, talk to your doctor.

Other medicines and Amlodipin-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Amlodipin-ratiopharm may affect or be affected by other medicines, such as:
-   ketoconazole, itraconazole (anti-fungal medicines)
-   ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
-   rifampicin, erythromycin, clarithromycin (for infections caused by bacteria)
-   hypericum perforatum (St. John’s Wort)
-   verapamil, diltiazem (heart medicines)
-   dantrolene (infusion for severe body temperature abnormalities)
-   tacrolimus (used to control your body’s immune response, enabling your body to accept the transplanted organ)
-   simvastatin (cholesterol lowering medicine)
-   cyclosporine (an immunosuppressant).
Amlodipin-ratiopharm may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Amlodipin-ratiopharm with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipin-ratiopharm. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipin-ratiopharm.

Pregnancy and breast-feeding

Pregnancy
The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipin-ratiopharm.
Breast-feeding
It is not known whether amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipin-ratiopharm.

Driving and using machines

Amlodipin-ratiopharm may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

3. How to take Amlodipin-ratiopharm

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Amlodipin-ratiopharm 5 mg
The recommended initial dose is 1 tablet (corresponding to 5 mg amlodipine) once daily. The dose can be increased to 2 tablets (corresponding to 10 mg amlodipine) once daily.
This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Amlodipin-ratiopharm with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.
The 2.5 mg dose can be obtained with Amlodipin-ratiopharm 5 mg as these tablets can be devided into equal doses.
Amlodipin-ratiopharm 10 mg
The recommended initial dose is 54 tablet (corresponding to 5 mg amlodipine) once daily. The dose can be increased to 1 tablet (corresponding to 10 mg amlodipine) once daily.
This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Amlodipin-ratiopharm with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.
The 2.5 mg dose cannot be obtained with Amlodipin-ratiopharm 10 mg.
Amlodipin-ratiopharm 10 mg can be divided into equal doses.
It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.

If you take more Amlodipin-ratiopharm than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipin-ratiopharm.

If you forget to take Amlodipin-ratiopharm

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

If you stop taking Amlodipin-ratiopharm

Your doctor will advise you how long to take this medicine. Your condition may return if you stop using this medicine before you are advised.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Visit your doctor immediately if you experience any of the following side effects after taking this medicine.
Common: may affect up to 1 in 10 people
-   Shortness of breath or difficulty in breathing
Uncommon: may affect up to 1 in 100 people
-   Chest pain
-   Abnormal heart beat
Very rare: may affect up to   1    in    10,000 people
-   Sudden wheeziness
-   Swelling of eyelids, face    or    lips
-   Swelling of the tongue and throat which causes great difficulty breathing
-   Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions
-   Heart attack
-   Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell
The following very common side effect has been reported. If this causes you problems or if it lasts for more than one week, you should contact your doctor.
Very common: may affect more than 1 in 10 people
-   Oedema (fluid retention)
The following common side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Common: may affect up to 1 in 10 people
-   Headache, dizziness, sleepiness (especially at the beginning of treatment)
-   Palpitations (awareness of your heart beat), flushing
-   Abdominal pain, feeling sick (nausea)
-   Altered bowel habits, diarrhoea, constipation, indigestion
-   Tiredness, weakness
-   Visual disturbances, double vision
-   Muscle cramps
-   Ankle swelling
Other side effects that have been reported include the following list. If any of these get 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 changes, anxiety, depression, sleeplessness
-   Trembling, taste abnormalities, fainting
-   Numbness or tingling sensation in your limbs, loss of pain sensation
-   Ringing in the ears
-   Low blood pressure
-   Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
-   Cough
-   Dry mouth, vomiting (being sick)
-   Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
-   Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
-   Inability to obtain an erection, discomfort or enlargement of the breasts in men
-   Pain, feeling unwell
-   Joint or muscle pain, back pain
-   Weight increase or decrease
Rare: may affect up to 1 in 1,000 people
-   Confusion
Very rare: may affect up to 1 in 10,000 people
-   Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding
-   Excess sugar in blood (hyperglycaemia)
-   A disorder of the nerves which can cause muscular weakness, tingling or numbness
-   Swelling of the gums
-   Abdominal bloating (gastritis)
-   Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests
-   Increased muscle tension
-   Inflammation of blood vessels, often with skin rash
-   Sensitivity to light
Not known: frequency cannot be estimated from the available data
-   Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Amlodipin-ratiopharm

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Store in the original package in order to protect from light and moisture.
HDPE bottle:
Shelf life after first opening: 4 months
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Amlodipin-ratiopharm contains

- The active substance is amlodipine.
Amlodipin-ratiopharm 5 mg
Each tablet contains 5 mg amlodipine (as besilate)
Amlodipin-ratiopharm 10 mg
Each tablet contains 10 mg amlodipine (as besilate)
- The other ingredients are microcrystalline cellulose (E 460), calcium hydrogen phosphate, anhydrous (E 341), sodium starch glycolate (Type A), magnesium stearate (E 470b).

What Amlodipin-ratiopharm looks like and contents of the pack

Amlodipin-ratiopharm 5 mg
White, round tablets. One side is slightly concave with a breakline and debossed “A5”. The other side is slightly convex and plain.
Amlodipin-ratiopharm 10 mg
White, round tablets. One side is slightly concave with a breakline and debossed “A10”. The other side is slightly convex and plain.
They are available in PVC/PVDC/Al blister packs with 10, 14, 20, 28, 30, 30x1, 50, 50x1, 60, 90, 98, 100, 100x1, 200, 250 tablets.
They are available in HDPE bottles with 100 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH,
Graf-Arco-Str. 3,
89079 Ulm,
Germany

Manufacturers

Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren,
Germany
Teva Pharmaceutical Works Private Limited Company Pallagi ut 13,
4042 Debrecen,
Hungary
Teva Pharma S.L.U.
Poligono Industrial Malpica, calle C, numero 4 50016 Zaragosa,
Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonian representative UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Phone: +372 6610801

This leaflet was last revised in November 2017.






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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