Document: leaflet MAH GENERIC_PL 25258-0215 change

• leaflet MAH GENERIC_PL 25258-0215
• leaflet MAH GENERIC_PL 39560-0002

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Company name    Module 1.3.1.3

Product name Diltiazem HC1 200 mg and 300 mg    Package Leaflet

prolonged-release capsules, hard

Package leaflet: Information for the user

Diltiazem HCl 200 mg and Diltiazem HCl 300 mg

Diltiazem Hydrochloride

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.

What is in this leaflet:

1.    What Diltiazem HCl is and what it is used for

2.    What you need to know before you use Diltiazem HCl

3.    How to take Diltiazem HCl

4.    Possible side effects

5.    How to store Diltiazem HCl

6.    Contents of t he pack and other information

1.    What Diltiazem HCl is and what it is used for

Diltiazem HCl contains a medicine called diltiazem. This belongs to a group of medicines called ‘calcium-channel blockers’.

Diltiazem HCl is used for:

•    High blood pressure

•    Angina (chest pain).

It works by making your blood vessels wider. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around your body. This helps to prevent the chest pain caused by angina.

2.    What you need to know before you take Diltiazem HCl Do not take Diltiazem HCl:

•    if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    if you have a very slow heartbeat - less than 50 beats per minute

•    if you have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out of breath and have swollen ankles

•    if you have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker).

•    if you are taking a dantrolene infusion used for severe muscle spasm or serious fever (called “malignant hyperthermia”).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Diltiazem HCl.

Warnings and precautions

Talk to your doctor or pharmacist before taking Diltiazem HCl:

•    if you have any other problem with your heart, apart from angina or those described in the Section above ‘Do not take Diltiazem HCl’

•    if you are going to have an operation

•    if your are at risk of mood changes, including depression

•    if you are at risk of gut problems.

•    if you have liver problems

•    if you have kidney problems

•    if you are elderly

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Diltiazem HCl.

Other medicines and Diltiazem HCl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Diltiazem HCl can affect the way some other medicines work. Also some medicines can affect the way Diltiazem HCl works.

In particular, do not take this medicine and tell your doctor if you are taking:

•    Dantrolene (an infusion) used for severe muscle spasms or serious fever (called ‘malignant hyperthermia’).

•    Nifedipine

•    Ergot derivatives (ergotamine, dihydroergotamine)

•    Cisapride

•    Sertindole

•    Pimozide

The use of Diltiazem HCl concomitantly with the following medicine is not recommended:

•    Ivabradine

Take special care with the concomitant use of Diltiazem HCl with the following medicine:

•    medicinal products inducing torsades de pointes, such as phenothiazines, bepridil, certain oral macrolides (such as erythromycin), terfenadine and Calss I and III antiarrhythmics, methadone.

Diltiazem HCl may increase the effect of the following medicines:

•    Medicines    for high    blood pressure such as doxazosin, tamsulosin, atenolol, propranolol

or acebutolol

•    Medicines used    for an uneven heartbeat    such as    amiodarone,    digoxin    and dronedarone

•    Medicines used    for angina such as glyceryl    trinitrate or isosorbide trinitrate

•    Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin

•    Medicines used for sleeplessness and anxiety, such as triazolam and midazolam

•    Carbamazepine - used for epilepsy

•    Theophylline - used for breathing problems

Module 1.3.1.3 Package Leaflet

•    Lithium - used for some types of mental illness

•    Methylprednisolone - used for inflammation and allergic reactions

•    Immunosuppressants (ciclosporine, tacrolimus, sirolimus, everolimus) - used to stop the rejection of organs after a transplant.

Diltiazem HCl may make the following medicine work less well:

•    Rifampicin - used for tuberculosis.

The following medicines can increase the effect of Diltiazem HCl

•    Medicines for stomach ulcers such as cimetidine and ranitidine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Diltiazem HCl.

Pregnancy, breast-feeding and fertility

•    Diltiazem HCl may impair fecundation and cause fetal abnormalities.

•    If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, Diltiazem HCl is not recommended. This is because Diltiazem HCl can cause problems for your baby.

•    Breast-feeding during the use of Diltiazem HCl is not recommended, since small amounts may pass into the mother’s milk. .

Driving and using machines

You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.

3. How to take Diltiazem HCl

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Also ask your doctor if you feel the effect of your medicine is too weak or too strong. Do not change the dose yourself.

Taking this medicine:

•    Take this medicine by mouth.

•    Do not break, crush or chew your capsules.

•    Swallow the capsules whole with a drink of water.

•    Take before or during a meal.

How much to take Adults:

•    The usual starting dose is one Diltiazem HCl 200 mg capsule a day.

If necessary, your doctor may increase your dose. Possible doses are:

•    One Diltiazem HCl 300    mg capsule a day

•    Two Diltiazem HCl 200    mg capsules a day

•    One Diltiazem HCl 300    mg capsule and one    Diltiazem HCl 200 mg capsule a day.

Over 65 years or adults with    liver or kidney problems

•    Your doctor will check you more closely particularly when you first start taking the capsules.

•    The usual starting dose is one Diltiazem HCl 200 mg capsule a day.

If necessary, your doctor may increase this to:

• One Diltiazem HCl 300 mg capsule a day.

Children:

Diltiazem HCl should not be given to children.

Sun protection

You should use sun protection whilst taking this medicine.

Tests

Your doctor may do regular tests while you are taking this medicine. These might include a check on your heart. It may also include blood tests to check your liver and kidneys.

If you take more Diltiazem HCl than you should

If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, being short of breath, fainting, an unusually fast or slow heartbeat, coma, slurred speech and confusion.

If you forget to take Diltiazem HCl

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Diltiazem HCl

Keep taking Diltiazem HCl until your doctor tells you to stop. Do not stop taking Diltiazem HCl just because you feel better. If you stop, your illness may get worse.

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 everyone gets them.

Stop taking Diltiazem HCl and see a doctor or go to a hospital straight away if:

It is not known how often these side effects happen

•    You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue

•    You get blistering or peeling of the skin around the lips, eyes, mouth, nose or genitals, flulike symptoms or fever. This could be an illness called “Stevens-Johnson syndrome”

•    You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may feel generally unwell, have a fever, chills or aching muscles. This could be an illness called “Toxic Epidermal Necrolysis”

•    You have a skin rash or skin problems with a pink or red ring and a pale centre which may be itchy, scaly, or filled with fluid. The rash is most likely to happen on the palms or soles or your feet. These could be signs of a serious allergy to the medicine called “erythema multiforme”.

Stop taking Diltiazem HCl and see a doctor or go to hospital straight away, if you notice any of the side effects above.

Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

Common (affects less than 1 in 10 people)

•    Slow or uneven heartbeat

•    Very fast, uneven or forceful heartbeat (palpitations).

It is not known how often these side effects happen

•    Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’)

•    Being short of breath, feeling tired along with swollen ankles or legs. These could be signs of heart failure

•    Unusual movements of the tongue, muscle spasms in your face, rolling eyes or trembling

•    High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (called ‘hepatitis’)

•    Getting sunburnt more easily and more severely than someone not taking Diltiazem HCl. You should use sun protection whilst taking this medicine

•    Breast enlargement in men.

Tell your doctor straight away if you notice any of the side effects above.

Tell your doctor as soon as possible if you have any of the following side effects:

Very common (affects more than 1 in 10 people)

•    Swelling of the lower legs.

Common (affects less than 1 in 10 people)

•    Indigestion, stomach pain, constipation or diarrhoea.

Uncommon (affects less than 1 in 100 people)

•    Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure).

Rare (affects less than 1 in 1,000 people)

•    Dry mouth

•    Itchy, lumpy rash (called ‘urticaria’).

It is not known how often these side effects happen

•    Swollen gums.

Tell your doctor as soon as possible if you notice any of the side effects above.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

Common (affects less than 1 in 10 people)

•    Headache

•    Flushing (feeling of warmth)

•    Feeling sick (nausea) or being sick (vomiting)

•    General feeling of being unwell

•    Feeling weak or tired

•    Feeling dizzy

•    Skin redness.

Uncommon (affects less than 1 in 100 people)

•    Difficulty sleeping.

•    Nervousness

It is not known how often these side effects happen

•    Mood changes, including depression

•    Bleeding or bruising under the skin.

•    gingival hyperplasia

•    decrease of platelets (thrombocytopenia

Tell your doctor or pharmacist if any of the side effects above get serious or last longer than a few days.

Blood tests

Diltiazem HCl can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5.    How to store Diltiazem HCl

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 after ‘EXP’. The expiry date refers to the last day of that month.

Store in the original packaging.

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 Diltiazem HCl contains

-    The active substance is Diltiazem Hydrochloride.

-    The other ingredients are (for Diltiazem HCl 200 mg) povidone, talc, ethylcellulose, stearic acid, gelatine and titanium dioxide (E171).

-    The other ingredients are (for Diltiazem HCl 300 mg) povidone, talc, ethylcellulose, stearic acid, gelatine and titanium dioxide (E171), quinoline yellow (E104) and indigotine carmine (E132).

What Diltiazem HCl 200 mg and Diltiazem HCl 300 mg look like and contents of the pack

•    Diltiazem HCl 200mg capsules are opaque capsules with a white body and cap.

•    Diltiazem HCl 300mg capsules are opaque capsules with a white body and green cap.

•    The capsules are provided in blister packs containing 7 or 28 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue,

Kenton, Middlesex, HA3 0BU United Kingdom

Manufacturer 1:

Lamp San Prospero S.p.A.

Via della Pace 25/A,

41030 San Prospero, Modena Italy

Manufacturer 1:

Farmea

Rue Bouche Thomas, 10 ZAC D'Orgemont 49007 Angers Cedex France

This medicinal product is names:

Portugal    Diltiazem

Diltiazem Germany    Diltiazem

Diltiazem France    Diltiazem

Diltiazem Spain    Diltiazem

Diltiazem

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 08/2016

UK - Change of Ownership Application

August 2016

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