300 mg capsules, hard 
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, pharmacist or nurse.
  • 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, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Clindamycin Alternova is and what it is used for 
2. What you need to know before you use Clindamycin Alternova 
3. How to use Clindamycin Alternova 
4. Possible side effects 
5. How to store Clindamycin Alternova 
6. Package contents and other information

1. What Clindamycin Alternova is and what it is used for

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

Clindamycin contained in Clindamycin Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Clindamycin Alternova

Do not use Clindamycin Alternova

  • if you are allergic to clindamycin 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, pharmacist or nurse before using Clindamycin Alternova:

  • if you have or have had a bowel disease before. If you have it, you should inform your doctor before starting treatment with Clindamycin Alternova.

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

If you get diarrhea during treatment, contact your doctor so that the treatment can either be stopped or continued under close supervision.

Infection is

The use of clindamycin can cause 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.

Other medicines and Clindamycin Alternova

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.

This is especially true if you use:

  • 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 blood thinners. You may be more likely to have bleeding. Your doctor may need to take regular blood tests to check how well your blood is clotting (coagulating).

Clindamycin Alternova with food and drink

Clindamycin Alternova can be taken with food and drink.

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. Therefore, consult a physician before using Clindamycin Alternova. Clindamycin Alternova should not be used during the first three months of pregnancy as there is insufficient information on safety.

If you are pregnant, you should only use Clindamycin Alternova 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 Clindamycin Alternova while breast-feeding.

Fertility

In animal fertility studies, clindamycin showed no effects on fertility or fertility .

Driving and using machines

Clindamycin Alternova has no effect on 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.

Clindamycin Alternova 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.

3. How to use Clindamycin Alternova

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. The capsules should be swallowed whole with a glass of water and taken in a sitting or standing position. The capsules should not be split due to the risk of damage to the pharynx.

Use for children and adolescents

If the child is unable to swallow capsules, other forms of clindamycin may be more appropriate.

If you forget to use Clindamycin Alternova

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

If you stop using Clindamycin Alternova

It is important that the entire course is completed according to the doctor’s instructions, otherwise an infection may flare up again.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse .

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 Clindamycin Alternova:

  • 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).

Clindamycin Alternova 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 (may affect up to 1 in 10 people)

  • abdominal pain
  • diarrhea
  • abnormal liver values

Uncommon side effects (may affect up to 1 in 100 people)

  • hives or other rashes
  • vomiting
  • nausea

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
  • an increased amount of certain white blood cells ( eosinophilia )
  • changed taste
  • sores in the esophagus
  • inflammation of the esophagus
  • jaundice
  • allergic reactions
  • measles-like rash
  • itching

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

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 Clindamycin Alternova

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

Store below 30 ° C.

Do not use this medicine after the expiry date which is stated on the carton and blister 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

  • The active substance is clindamycin hydrochloride equivalent to clindamycin 300 mg.
  • The other ingredients are lactose monohydrate , corn starch, magnesium stearate, talc, gelatin, patent blue V (E131) and titanium dioxide (E 171).

What the medicine looks like and contents of the pack

Turquoise capsule.

Blisters: 4, 8, 16, 20, 24, 32, 40 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Alternova A / S

Lodshusvej 11

4230 Skælskør

Manufacturer:

Chanelle Medical

Loughrea

Co. Galway

Ireland

Or

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Muhammad Nadeem

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