125 mg, 500 mg, and 1 g film-coated tablets
flucloxacillin

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 you will find information about:
1. What Heracillin is and what it is used for
2. What you need to know before using Heracillin
3. How to use Heracillin
4. Possible side effects
5. How to store Heracillin
6. Contents of the packaging and other information

1. What Heracillin is and what it is used for

The active substance in Heracillin, flucloxacillin, is penicillin (antibacterial drug), which prevents the bacterium from building a normal cell wall. Without a functioning cell wall, the bacterium dies quickly. Heracillin differs from regular penicillin in that it is stable against an enzyme ( beta-lactamase ), which has the ability to break down regular penicillin.

Heracillin is used in infections of the skin and soft tissues and infections of the joints, bones, and lungs.

Flucloxacillin contained in Heracillin 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 you use Heracillin

Do not use Heracillin

  • If you / your child are allergic to penicillin or any of the other ingredients of this medicine (listed in section 6)

Warnings and cautions

Talk to your doctor or pharmacist before using Heracillin.

  • If you / your child are hypersensitive to cephalosporins (another group of antibacterial drugs), consult your doctor before using Heracillin.
  • There is a risk of diarrhea and colon infection. If you have problems with diarrhea, you should therefore consult a doctor.
  • There is a risk of liver damage, it is rare but probably increases with older age and with longer treatment.
  • If you are taking or will be taking paracetamol .

The use of flucloxacillin, especially in high doses, may lower blood potassium levels ( hypokalaemia ). Your doctor may want to measure your potassium levels regularly during treatment with higher doses of flucloxacillin.

With concomitant use of flucloxacillin and paracetamol, there is a risk of blood and fluid disturbances (metabolic acidosis due to high anion gap, so-called HAGMA), which occurs when the acidity in plasma increases, especially in certain patient groups who have an increased risk, e.g. patients with severe renal impairment, sepsis or malnutrition and especially when using maximum daily doses of paracetamol. HAGMA is a serious condition that requires urgent treatment.

Other drugs and Heracillin

Tell your doctor or pharmacist if you / your child have recently taken or might take any other medicines. The effects of certain medicines can affect or be affected by the treatment with Heracillin, for example, some medicines for tumors and disorders of the immune system (methotrexate), for gout (probenecid), and some blood thinners ( warfarin ).

Heracillin with food and drink

Heracillin has the best effect if the medicine is taken between meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

No known risks when used during pregnancy.

Flucloxacillin passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if more than occasional use of Heracillin during breastfeeding.

Driving and using machines

Heracillin has no or negligible effect on the ability to drive and use machines. If you get dizzy, do not drive or 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.

Heracillin contains sodium

The 125 mg tablet contains less than 1 mmol (23 mg) sodium, ie it is essentially ‘sodium-free.

The 500 mg tablet contains 29 mg of sodium, (the main ingredient in table salt/table salt). This corresponds to 1.5% of the highest recommended daily intake of sodium for adults.

1 g tablet contains 58 mg sodium. This corresponds to 3% of the maximum recommended daily intake of sodium for adults.

This should be considered by patients on a low-salt diet.

3. How to use Heracillin

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

Your doctor will decide on a dose that suits you / your child. Even if you / your child feels better already after a few days, it is important that the entire treatment is completed according to the prescription. Otherwise, some bacteria may survive for a while, grow and cause a new outbreak of infection.

Take flucloxacillin tablets at least 1 hour before or 2 hours after a meal.

To reduce the risk of esophageal pain, swallow the tablets with a full glass of water (250 ml). Do not lie down immediately after taking the tablets.

If you take more Heracillin than you should

If you / your child has ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Heracillin

If you forget to take a dose , take it as soon as possible. Then continue as before. 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.

Contact a doctor immediately if any of the following serious side effects occur:

Heracillin 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 problems urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytos ). It is important that you then inform about your medication.

Heracillin may in rare cases give rise to a severe acute allergic reaction ( anaphylactic reaction ). Such a reaction can be life-threatening. If one or more of the following symptoms occur, contact a doctor or emergency room immediately. The symptoms of such a reaction may be reddening of the skin, itchy hives ( urticaria ), shortness of breath and dizziness.

Tell your doctor immediately if you have prolonged or severe diarrhea. This may be a sign of colon inflammation caused by the Clostridium difficile bacterium and may require treatment. This side effect is rare.

Serious skin side effects have been reported (occurring in an unknown number of users). Red scaly rash with bumps under the skin and blisters (exanthematous pustulosis ). Contact a doctor immediately if you get any of these symptoms.

Other side effects:

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

  • Stomach upset, mainly nausea or diarrhea
  • Rash

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

  • Hives
  • Hematopoiesis ( eosinophilia )

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

  • Liver effects

Very rare (may affect up to 1 in 10,000 people):

  • Itching
  • Blood and fluid disturbances (metabolic acidosis due to high anion gap), which occurs when the acidity of blood plasma increases, with concomitant use of flucloxacillin and paracetamol , usually in patients with risk factors (see section 2).

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

  • Low potassium levels in the blood ( hypokalaemia ) that can cause muscle weakness, twitching or abnormal heart rhythm. Dizziness, abdominal pain, vomiting. Pain in the esophagus and other related symptoms, such as difficulty swallowing, heartburn, throat irritation and chest pain.

Itching in the abdomen can be caused by fungal overgrowth.

White coating in the mouth mainly on the tongue can also be caused by fungal infection.

There is a risk of liver damage, it is rare but probably increases with older age and longer treatment.

Reporting of side effects

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. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Heracillin

1 g tablet: Do not store above 30 ° C.

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 or label after EXP or EXP. The expiration date is the last day of the specified month.

Tablets in pressure packing (single dose) have a shelf life limited to 6 months after the outer aluminum bag has been opened. After “OPENING DATE”, the date of opening is written, both on the aluminum bag and on the cartons that enclose the printing packaging.

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 flucloxacillin. One tablet contains flucloxacillin sodium monohydrate equivalent to flucloxacillin 125 mg, 500 mg and 1 g respectively.
  • The other ingredients are: Magnesium stearate, povidone, croscarmellose sodium, microcrystalline cellulose. Film coating: dye (titanium dioxide E 171), macrogol, paraffin, hypromellose.

What the medicine looks like and contents of the pack

125 mg: White, oblong tablet, 5.2 x 10 mm.

500 mg: White, oblong tablet, with a score line on one side, 8 x 17 mm.

1 g: White, elliptical, tablet with a score line and marked

with A on one side, 9.6 x 21 mm.
HAVE

The 500 mg and 1 g tablets can be divided into two equal parts.

Pack sizes

125 mg: 30 tablets in a plastic jar.

500 mg: 30, 50 and 100 tablets in a plastic jar and 98 (2 x 49) x 1 tablets in a pressure pack (single dose).

1 g: 21, 30, 50 and 75 tablets in a plastic jar.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Meda AB

Box 906

170 09 Solna

Phone 08-630 19 00

Muhammad Nadeem

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