Package leaflet: Information for the user

Dicloxacillin Orion 250 mg capsules, hard Dicloxacillin Orion 500 mg capsules, hard

dicloxacillin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet 1. What Dicloxacillin Orion is and what it is used for 2. What you need to know before you take Dicloxacillin Orion 3. How to take Dicloxacillin Orion 4. Possible side effects 5. How to store Dicloxacillin Orion 6. Contents of the pack and other information

1. What Dicloxacillin Orion is and what it is used for Dicloxacillin, the active ingredient in Dicloxacillin Orion, belongs to the group of medicines called penicillins (antibiotics) that prevent bacteria from building up a normal cell wall. Dicloxacillin Orion is used for the treatment of infections caused by certain types of staphylococci.

Your doctor may have prescribed Dicloxacillin Orion to you to treat other illnesses. Always follow your doctor's instructions.

2. What you need to know before you take Dicloxacillin Orion

Do not take Dicloxacillin Orion - if you are allergic to dicloxacillin or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to penicillin. - if you have an allergic reaction (type I) to cephalosporins.

Warnings and precautions Talk to your doctor before taking Dicloxacillin Orion - if you are allergic to other medicines used for the treatment of infections (cephalosporins, cephamycins, 1-oxa-beta-lactams and carbapenems).

Contact your doctor immediately if you experience during the treatment - an allergic reaction (anaphylactic reaction); - severe or prolonged bloody diarrhoea (a symptom of antibiotic-associated colitis).

Please note that your doctor may monitor your liver and kidney function and blood count, especially if the treatment continues for longer periods. Close monitoring is necessary if the medicine is given to a newborn baby.

Children Dicloxacillin Orion cannot be given to premature and newborn babies. Dicloxacillin Orion is not recommended for children weighing less than 20 kg.

Other medicines and Dicloxacillin Orion Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to medicines available without a prescription, herbal products and nutritional supplements.

Talk to your doctor, if you take: - medicines containing probenecid (for gout), since these may elevate the concentration of dicloxacillin in your blood; - contraceptive pills, since dicloxacillin may in rare cases reduce their efficacy; - warfarin/dicoumarol (blood-thinning medicines), since dicloxacillin may reduce their efficacy; - methotrexate (medicine for the treatment of arthritis), since dicloxacillin may lead to increased risk of side effects from methotrexate. - other antibiotics (e.g. tetracycline), since they may reduce dicloxacillin efficacy.

Dicloxacillin Orion with food and drink Do not take Dicloxacillin Orion with a meal. Capsules must be swallowed whole with at least half a glass of water. Do not take the capsules in a lying position or immediately before bedtime. The dose must be taken at least 1 hour before or 2 hours after a meal.

Pregnancy, breast-feeding 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 Dicloxacillin should not be used during pregnancy. Consult your doctor before using Dicloxacillin Orion if you are pregnant.

Breast-feeding Dicloxacillin passes into the breast milk. Consult your doctor before using Dicloxacillin Orion.

Driving and using machines There are no known effects on the ability to drive or use machines.

Dicloxacillin Orion contains sodium This medicinal product contains 0.6 mmol (or 12.7 mg) sodium in one 250 mg capsule and 1.1 mmol (or 25.3 mg) sodium in one 500 mg capsule. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Dicloxacillin Orion

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults The recommended dose is 500 mg to 1 g 3-4 times daily. In severe and serious infections, the daily dose may be increased to a maximum of 6 grams.

Children 20-40 kg The recommended dose is 250 mg 3-4 times daily. In severe and serious infections the daily dose may be doubled.

Children (>40 kg) The recommended dose is 500 mg 3-4 times daily. In severe and serious infections, the daily dose may be increased to a maximum of 6 grams.

Since the experience from use in premature and neonate babies is limited, no dose recommendations can be given for this age group. Capsules are not recommended for use in children under 20 kg in weight.

Impaired kidney function It may be necessary to reduce the dose. Follow your doctor's advice.

The capsules must be swallowed whole with at least half a glass of water and not in a lying position or immediately before bedtime. The dose must be taken at least 1 hour before or 2 hours after a meal. Always follow your doctor's instructions.

If you take more Dicloxacillin Orion than you should If you have taken too much of the medicine or if a child, for example, has accidentally taken this medicine, contact your doctor or hospital for an assessment of the risk and to receive advice. Symptoms of an overdose may include abdominal discomfort, disturbances in the electrolyte balance, cramps, impaired consciousness and kidney failure.

If you forget to take Dicloxacillin Orion Take the forgotten dose as soon as you remember. Take the following dose first after 4 hours so that the amount of this medicine stays even in your body. After this continue taking the medicine according to the instructions. Remember to take the medicine regularly. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people):  diarrhoea, nausea, vomiting, digestive problems and flatulence  skin rash

Uncommon (may affect up to 1 in 100 people):  nettle rash and itching

Rare (may affect up to 1 in 1,000 people):  severe allergic reactions (an anaphylactic reaction)  blood count disturbances and degradation of the blood cells (agranulocytosis, eosinofilia, thrombocytopenia, neutropenia, bone marrow depression, haemolytic anemia, leukopenia, granulocytopenia)  low blood pressure, shock and death  breathing difficulties, asthmatic breathing, sneezing, swelling of the throat  gullet pain, inflammation in the gullet, ulcers in the gullet, abdominal pain, pseudomembranous colitis (inflammation in the large intestine)  cholestatic hepatitis(jaundice with itching)  angioneurotic oedema (Quincke’s oedema) (rapid swelling of the skin and mucous membranes e.g. of the face and throat)  joint pain, muscle pain  different types of kidney diseases that may lead to impaired kidney function. Blood in the urine, foaming urine due to proteins present in the urine.  fever

Not known (frequency cannot be estimated from the available data):  fungal infections of the mouth and abdomen  increased sensitivity  serum sickness (slowly developing hypersensitivity reaction that can cause symptoms such as fever, general ill feeling, itching, pain in the joints, rashes and swollen lymph nodes)  liver injury  muscle twitching  malaise  increased blood creatinine; transient, asymptomatic increases in alkaline phosphatase, ASAT and ALAT

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dicloxacillin Orion

Keep this medicine out of the sight and reach of children. Store below 30°C. Store in the original package in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dicloxacillin Orion contains - The active substance is dicloxacillin sodium equivalent to 250 mg or 500 mg dicloxacillin in one capsule. - The other ingredients are:  capsule content: magnesium stearate and colloidal anhydrous silica  capsule shell: gelatin, water and titanium dioxide (E 171)  printing ink: shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide and purified water.

What Dicloxacillin Orion looks like and contents of the pack

Dicloxacillin Orion 250 mg capsules, hard: Off-white/Off-white size ‘2’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘Y’ on off-white cap & ‘14’ on off-white body in black ink.

Dicloxacillin Orion 500 mg capsules, hard: Off-white/Off-white size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘Y’ on off-white cap & ‘15’ on off-white body in black ink.

Pack sizes: 30, 50 and 100 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder Orion Corporation Orionintie 1 FI-02200 Espoo Finland

Manufacturer Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland

This medicinal product is authorised in the Member States of the EEA under the following names: Dicloxacillin Orion (Denmark, Iceland, Norway)

This leaflet was last revised in 11/06/2018.