20 mg / mL concentrate for infusion solution 
doxycycline

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.

– 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 Doxyferm is and what it is used for 
2. What you need to know before you are given Doxyferm 
3. How to use Doxyferm 
4. Possible side effects 
5. How to store Doxyferm 6. Contents of the pack 
and other information

1. What Doxyferm is and what it is used for

Doxyferm is an antibiotic that prevents the growth of bacteria.

Doxyferm is used in the treatment of pulmonary inflammation, acute worsening of chronic bronchitis ( bronchitis ), Chlamydia Infections of the genitourinary system. Lyme disease infection is after tick bites. Doxyferm is also used in acute sinusitis in patients who are hypersensitive to penicillins or when treatment with penicillins has not had the desired effect.

2. What you need to know before you are given Doxyferm

You should not be given Doxyferm

– If you are allergic to doxycycline, tetracyclines, or any of the other ingredients of this medicine (listed in section 6).

– If you are pregnant or planning to become pregnant

– If you are breast-feeding

Warnings and cautions

Talk to your doctor before using Doxyferm if you have myasthenia gravis (a disease that weakens the muscles).

During tooth development (children under 8 years, infants) Doxyferm should only be used on a doctor’s prescription because this type of medicine ( tetracyclines ) can affect the tooth enamel so that it discolors or develops incompletely and due to storage in the growing skeleton.

There may be circumstances (eg severe or life-threatening conditions), where your doctor may decide that the benefit outweighs the risk and Doxyferm should be prescribed to children under 8 years of age.

Due to the risk of allergic skin reactions, you should avoid sunbathing, including sunbathing in tanning beds, during the treatment period and for at least another 5 days after the end of the treatment.

Contact a doctor if you get prolonged and/or troublesome diarrhea.

Other medicines and Doxyferm

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

The following medicines should be avoided during treatment with Doxyferm:

  • antacids (for the treatment of acid reflux)
  • iron medicine
  • quinapril (for high blood pressure )
  • didanosine (for viral infections)
  • atovaquone (against pneumonia (pneumocystis carinii) and malaria )

Concomitant treatment with the following drugs may reduce the effect of Doxyferm

  • calcium (should be taken at least 3 hours before or after Doxyferm)
  • rifampicin (for tuberculosis )
  • phenobarbital, phenytoin, or carbamazepine (for epilepsy )

If you are taking anticoagulants at the same time during long-term treatment (medicines that reduce the blood’s ability to clot), talk to your doctor before using Doxyferm, as the dose for anticoagulants may need to be lowered.

Doxyferm with alcohol

The effect of Doxyferm may be affected by concomitant use of alcohol.

Pregnancy and breastfeeding

There is a risk of fetal harm. Doxyferm must therefore not be used during pregnancy.

Doxyferm passes into breast milk. Doxyferm must therefore not be used if you are breast-feeding.

Driving and using machines

Doxyferm 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 sharpened 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.

How to use Doxyferm

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

Your doctor will explain to you exactly how much Doxyferm you will receive as well as how often and for how long. This depends on the type of infection you have and how serious it is.

Your doctor will give each dose by slow infusion (drip) through a vein into the bloodstream. The infusion time can vary from ½ hour to 6 hours.

The recommended dose for adults and children from 12 years of age: 200 mg on the first day (in one or two infusions) followed by a maintenance dose of 100 mg/day. The treatment time depends on the infection being treated.

Use for children from 8 to 12 years:

For children aged from 8 years up to 12 years, Doxyferm should only be used when other medicines are not available or will not be effective. In such circumstances, the usual doses are:

For children weighing 45 kg or less: 
First day: 4.4 mg for each kg of body weight (on one or two infusions), then 2.2 mg for each kg of body weight (on one or two infusions) from the second day. The treatment time depends on the infection being treated. 
In case of a more severe infection, up to 4.4 mg for each kg of body weight should be given throughout the treatment.

ear children weighing over 45 kg:  same as the recommended dosage for adults.

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 a healthcare professional immediately if you get any of the following:

  • Rapid rash, fever, difficulty breathing, and/or swelling of the face ( anaphylactic reaction ). Your doctor may need to stop your treatment.
  • Skin changes or 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 (erythema multiforme, mucocutaneous syndrome).
  • Signs of Jarisch-Herxheimer reaction that causes fever, chills, headache, muscle aches, and rash. These symptoms are usually self-limiting. This occurs shortly after starting doxycycline treatment of infections caused by spirochete such as Lyme disease infection.

These side effects are rare and may affect up to 1 in 1,000 people.

Other side effects that may occur:

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

  • Nausea, vomiting, diarrhea.

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

  • Skin and hives
  • Hypersensitivity to sunlight (see also section “Warnings and precautions”).

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

  • Decreased platelet count ( thrombocytopenia )
  • Nail removal
  • Elevated pressure in the head (which may cause symptoms in the form of headache or decreased visual acuity )
  • Inflammation of the colon
  • Drug reaction that can manifest itself as fever, skin rash, altered blood picture, enlarged lymph nodes, and effects on internal organs (DRESS syndrome).

Unknown frequency (occurs in an unknown number of users):

  • discoloration and/or reduced growth of teeth

Fungal growth in the mucous membranes of the mouth or vagina can sometimes occur because the normal bacterial flora is affected, and can cause inflammation. If problems occur and persist for several days or are experienced as severe, contact a doctor.

5. How to store Doxyferm

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

Doxyferm concentrate for solution for infusion is light sensitive and should therefore be stored in the outer carton. Store in a refrigerator (2 ° C – 8 ° 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.

After dilution, the infusion solution should be consumed within 6 hours. The solution must be protected from direct sunlight.

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 doxycycline. 1 ml concentrate for solution for infusion contains doxycycline hyclate equivalent to 20 mg doxycycline.
  • The other ingredients are ethanolamine, magnesium chloride hexahydrate, povidone, acetylcysteine ​​, and water for injections.

What the medicine looks like and the contents of the pack

Concentrate for infusion solution.

Clear, yellowish liquid.

Glass ampoule is 5 x 5 ml. 1 ampoule of 5 ml contains 100 mg doxycycline .

Marketing Authorisation Holder

Nordic Drugs AB

Box 300 35

200 61 Limhamn

Muhammad Nadeem

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