15 mg / ml granules for oral solution 
clindamycin

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.

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

1. What Dalacin is and what it is used for

Dalacin is an antibacterial agent ( antibiotic ). Dalacin is used to treat infections in the throat and the skin and soft tissues.

Clindamycin contained in Dalacin 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 you use Dalacin

Do not use Dalacin

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to lincomycin.

Warnings and cautions

Talk to your doctor or pharmacist before using Dalacin:

  • if you have or have had before, any intestinal disease. If you have it, you should inform your doctor before starting treatment with Dalacin.
  • if you have impaired liver or kidney function.

During long-term treatment, liver and kidney function and blood should be examined regularly by your doctor.

Other medicines and Dalacin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines, including (traditional) herbal medicines and herbal medicines. Some medicines may affect the way this medicine works, or this medicine may affect the way other medicines are used at the same time.

Your doctor needs to know if you are using:

  • muscle relaxants
  • erythromycin, clarithromycin, telithromycin, rifampicin ( antibiotics, used to treat infections )
  • itraconazole, voriconazole (used to treat fungal infections)
  • ritonavir, cobicistat (used to treat HIV )
  • St. John’s wort ( Hypericum perforatum ) (used for mild depression and mild anxiety)
  • carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy )
  • dihydroergotamine, ergotamine (used for migraines )
  • ergometry (used during childbirth to reduce blood loss)
  • midazolam, triazolam (sedatives, hypnotics)
  • amiodarone, quinidine (used for irregular heartbeat)
  • cisapride (used to treat gastrointestinal disorders)
  • pimozide (used for mental health problems)
  • alfuzosin (used to treat benign prostatic hyperplasia)
  • simvastatin, lovastatin (a cholesterol-lowering drug)
  • sildenafil (used to treat erection problems and high blood pressure in the lungs)
  • warfarin or similar medicines (used to make the blood thinner) may increase the risk of bleeding. Your doctor may need to perform regular tests on your blood to see how well your blood is coagulating.

Infection is

The use of clindamycin can cause an overgrowth of organisms that are not sensitive to clindamycin, especially yeast. Contact your doctor as soon as possible if you suspect that you have developed such an infection.

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

There is a risk that the fetus is affected. Talk to your doctor before using Dalacin. Dalacin should not be used during the first three months of pregnancy as there is insufficient safety information.

If you are pregnant, you should only use Dalacin after an in-depth discussion with your doctor who will determine if this treatment is right for you.

Breast-feeding

There is a risk that children who are breastfed will be affected. Talk to your doctor before using Dalacin while breast-feeding.

Driving and using machines

This medicine does not affect the ability to drive and use machines.

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

Dalacin oral solution contains sucrose and ethyl parahydroxybenzoate (E 214)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This should also be considered by patients with diabetes mellitus.

May be harmful to teeth. Careful oral hygiene is important. Brush your teeth twice daily with fluoride toothpaste.

Ethyl parahydroxybenzoate may cause an allergic reaction (possibly delayed).

3. How to use Dalacin

Always use this medicine exactly as your doctor 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. Dalacin can be taken with or without food. The entire course must be completed according to the instructions, otherwise, the infection can flare up again.

If you use more Dalacin then you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Dalacin

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

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.

Contact your doctor or nurse immediately if you experience the following side effects during treatment with Dalacin:

  • severe, persistent, or bloody diarrhea (which may be accompanied by abdominal pain or fever). This may be a sign of severe intestinal inflammation or inflammation of the lining of the colon (pseudomembranous colitis ). This common side effect can in very rare cases develop into life-threatening complications.
  • sudden wheezing, difficulty breathing or swallowing, swollen eyelids, face or lips, rash or itching (especially if it itches all over the body). This may be a sign of a severe hypersensitivity reaction (occurs in an unknown number of users).
  • a drug reaction with symptoms such as fever, rash, altered blood picture, enlarged lymph nodes, and effects on internal organs (DRESS syndrome, occurs in an unknown number of 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 (occurs in an unknown number of users).
  • inflamed and scaly skin, severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes) (occurs in an unknown number of users).

Dalacin can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis, occurs in an unknown number of users). It is important that you then information about your medication.

Other side effects:

Common side effects are (may affect up to 1 in 10)

  • the increased amount of certain white blood cells ( eosinophilia )
  • diarrhea
  • rash
  • abnormal liver values

Less common side effects are (may affect up to 1 in 100)

  • abdominal pain
  • vomiting

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

  • diarrhea caused by the bacterium Clostridium difficile
  • infection of the vagina
  • decreased amount of one or more types of white blood cells ( neutropenia, leukopenia )
  • decreased platelet count
  • changed taste
  • sores in the esophagus
  • inflammation of the esophagus
  • nausea
  • jaundice
  • allergic reactions
  • measles-like rash
  • hives
  • itching

Fungal overgrowth can cause infection in the oral cavity and abdomen.

5. How to store Dalacin

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

Use within two weeks after collection of the bottle from the pharmacy.

Do not store above 25 ° C. Store in protection from the cold, otherwise, the solution will be difficult to pour.

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 clindamycin 15 mg
  • The other ingredients are 379 mg sugar and poloxalcol, cherry flavor, dimethicone, ethyl parahydroxybenzoate (E 214)

What the medicine looks like and the contents of the pack

Glass bottle 80 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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