60 mg film-coated tablets, 90 mg prolonged-release tablets, 120 mg prolonged-release tablets, 180 mg prolonged-release tablets 
Diltiazem hydrochloride

Read all of this leaflet carefully before you start using 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.

This leaflet contains information about: 
1. What Cardizem / Cardizem Retard is and what it is used for 
2. What you need to know before you use Cardizem / Cardizem Retard 
3. How to use Cardizem / Cardizem Retard 
4. Possible side effects 
5. How to store Cardizem / Cardizem Retard 6. Contents of the pack 
and other information 

1. What Cardizem / Cardizem Retard is and what it is used for

Cardizem and Cardizem Retard are so-called calcium antagonists that inhibit the influx of calcium into certain cells. For the heart, it means a reduced amount of work and thus a reduced risk of overexertion of the heart muscle.

The risk of angina in the heart decreases. With high blood pressure, the blood vessels dilate, causing the blood pressure to drop. Cardizem Retard prolonged-release tablets contain diltiazem in a core surrounded by a small hole. The tablet shell passes unaffected through the intestine, while the active substance is released during the passage through the gastrointestinal tract.

Treatment of angina in the heart (stable angina pectoris ) and high blood pressure ( hypertension ).

2. What you need to know before using Cardizem / Cardizem Retard

Do not use Cardizem / Cardizem Retard

  • If you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • If you suffer from severe heart problems (eg certain types of heart block, acute myocardial infarction, heart failure, or heart rhythm disorders).
  • If you suffer from digitalis poisoning.
  • If you are already taking a medicine containing ivabradine to treat certain heart conditions.

Warnings and cautions

Talk to your doctor or pharmacist before using Cardizem / Cardizem Retard.

If you have any of the following conditions, you should consult a doctor before starting treatment with Cardizem / Cardizem Retard :

  • low blood pressure
  • narrowing of the great carotid artery
  • any heart disease that affects the rhythm of the heart
  • impaired renal or hepatic function
  • risk of developing intestinal obstruction (intestinal obstruction).

Calcium antagonists such as diltiazem may cause mood swings, including depression.

Stop taking Cardizem / Cardizem Retard and contact a doctor immediately if you get any of the following symptoms ( angioedema )

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Other medicines and Cardizem / Cardizem Retard

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

Some medicines may affect or be affected by treatment with Cardizem / Cardizem Retard, e.g. certain medicines:

  • for high blood pressure (nifedipine, beta-blockers, alpha-blockers and calcium channel blockers )
  • for high blood pressure and angina (amlodipine)
  • against angina (nitrate derivatives)
  • against heart rhythm disorders (eg amiodarone )
  • lipid-lowering drugs ( simvastatin )
  • against epilepsy (carbamazepine)
  • with sedative and hypnotic effect (midazolam, triazolam)
  • against anxiety and depression (buspirone, imipramine)
  • against pain during surgery (alfentanil)
  • in transplantation (cyclosporine)
  • against manic-depressive illness (lithium)
  • drugs which inhibit the formation of hydrochloric acid and which are used against e.g. gastric ulcer (ranitidine, cimetidine)
  • against tuberculosis (rifampicin)
  • against inflammatory diseases such as rheumatism, ulcerative colitis, and asthma(methylprednisolone)
  • drugs that suppress the immune system (sirolimus, temsirolimus, and everolimus).

The treating physician, therefore, needs to be aware of such concomitant medication. If you need anesthesia during an operation, the anesthetist should be informed that you are taking Cardizem / Cardizem Retard.

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.

There is a risk that the fetus is affected. Therefore, always consult a doctor before using Cardizem / Cardizem Retard during pregnancy.

It is possible that a breastfed baby may be affected. Therefore, do not use Cardizem / Cardizem Retard during breastfeeding other than on a doctor’s prescription.

Driving and using machines

During treatment with Cardizem / Cardizem Retard, side effects such as dizziness and malaise may occur. This should be taken into account when sharper attention is required, e.g. while driving or precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Cardizem contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Cardizem Retard contains sucrose and sodium

Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium

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

How to use Cardizem / Cardizem Retard

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

Dose one is determined by the doctor who adjusts it individually for you.

Cardizem tablets should be swallowed with at least ½ glass of liquid, can be divided but must not be chewed.

Cardizem Retard prolonged-release tablets should be swallowed whole with at least ½ glass of liquid for at least 15 minutes

before a meal. The prolonged-release tablets must not be divided or chewed.

If you forget to use Cardizem / Cardizem Retard

Do not take a double dose to make up for a forgotten tablet

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.

Stop taking Cardizem / Cardizem Retard and contact your doctor immediately if you get any of the following symptoms:

  • swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing ( angioedema ). May affect up to 1 in 1,000 users.
  • an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals ( Stevens-Johnson syndrome ). May affect up to 1 in 1,000 users.
  • severe skin damage (skin peeling and superficial mucosa) ( toxic epidermal necrolysis ). May affect up to 1 in 1,000 users.

Very common (may affect more than 1 user in 10):

  • fluid retention, swelling of the arms and legs (peripheral edema )

Common (may affect up to 1 in 10 people):

  • headache
  • dizziness
  • fatigue
  • heart block ( AV block I, II, or III)
  • herds
  • nausea
  • constipation
  • heartburn and acid reflux ( dyspepsia )
  • abdominal pain
  • rash
  • itching
  • feeling sick
  • flushing with a feeling of warmth
  • palpitation
  • liver effects

Uncommon (may affect up to 1 in 100 people):

  • nervousness
  • difficulty falling asleep
  • low heart rate
  • a sudden drop in blood pressure when getting up
  • vomiting
  • diarrhea
  • increased liver values ​​( AST, ALT, LDH, or ALP)

Rare (may affect up to 1 in 1,000 people ):

  • heart rhythm disorders (such as fast heart rate , extra beats)
  • aggravated angina
  • low blood pressure
  • dry mouth
  • hives
  • ankle swelling
  • muscle and joint pain
  • skin and mucosal disorders (sometimes severe)
  • sleep disorders
  • confusion
  • hepatitis

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

  • decreased platelet count in the blood
  • mood swings (including depression)
  • involuntary muscle movements (extrapyramidal syndrome)
  • short, involuntary muscle twitching (myoclonus)
  • heart failure
  • inflammation of a vessel wall ( vasculitis )
  • gum swelling
  • photosensitivity ( photosensitivity )
  • rash
  • scaly skin inflammation (exfoliative dermatitis )
  • blisters on the body ( pustulosis )
  • sometimes scaly redness with or without fever (desquamative erythema )
  • sweating
  • enlargement of the mammary glands.

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 Cardizem / Cardizem Retard

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

Do not store above 25 ° C.

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

Cardizem

The active substance is Diltiazem hydrochloride 60 mg per tablet.

The other ingredients are Povidone, magnesium stearate, macrogol 6000, anhydrous lactose 260 mg/tablet, vegetable oil, talc, hypromellose, ethylcellulose.

Cardizem Retard

The active substance is Diltiazem hydrochloride 90 mg, 120 mg, and 180 mg per tablet respectively.

The other ingredients are: Povidone, magnesium stearate, macrogol 6000, sodium dihydrogen citrate, sucrose 50 mg, 69 mg and 155 mg per prolonged-release tablet, polymer coating, acetyl tributyl citrate, polymerized castor oil, sodium bicarbonate, ethylvanillin, titanium dioxide (dye E1) (dye).

What the medicine looks like and the contents of the pack

Appearance:

Cardizem 60 mg: white, round, film-coated tablet, scored on one side. The notch is not intended for splitting the tablet.

Cardizem Retard 90 mg, 120 mg, 180 mg: white, cupped, round tablet.

Pack sizes:

Cardizem 60 mg film-coated tablets

PVC / PVDC / aluminum blister pack containing 49×1 tablets (single dose pack).

HDPE jar with a lid in polyethylene (PE) containing 300 tablets.

Cardizem Retard 90 mg prolonged-release tablet is

PVC / PVDC / aluminum blister pack containing 49×1 tablets (single-dose pack) and HDPE jar with a child-resistant lid in polypropylene (PP) containing 30 and 200 tablets respectively.

Cardizem Retard 120 mg prolonged-release tablet is

PVC / PVDC / aluminum blister pack containing 49×1 tablets (single-dose pack) and HDPE jar with a child-resistant lid in polypropylene (PP ) containing 30 and 200 tablets respectively.

Cardizem Retard 180 mg prolonged-release tablet is

PVC / PVDC / aluminum blister pack containing 49×1 tablets (single-dose pack) and HDPE jar with a child-resistant lid in polypropylene (PP) containing 200 tablets.

The jar with the child-resistant lid is opened by holding the lid down and screwing it counterclockwise.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 52 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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