Active ingredient
- azithromycin dihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0873.
Azithromycin 250 mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Azithromycin 250 mg Capsules
(azithromycin dihydrate)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Azithromycin is and what it is used for
2. What you need to know before you use Azithromycin
3. How to take Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information
1. What Azithromycin is and what it is used for
Azithromycin is an antibiotic. It belongs to a group of antibiotics called 'macrolides'.
Azithromycin is used to treat bacterial infections caused by 'micro-organisms' such as bacteria. These infections include:
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you use Azithromycin
Do not take Azithromycin if
Warnings and precautions
Talk to your doctor or pharmacist before taking Azithromycin if you have or have had any of the following conditions:
Tell your doctor immediately if you feel your heart beating in your chest or have an abnormal heartbeat, or get dizzy or faint or suffer from any muscle weakness when taking Azithromycin.
If you develop diarrhoea or loose stools during or after treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues, please inform your doctor.
Other medicines and Azithromycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Azithromycin may interact with the medicines listed below:
Azithromycin with food and drink
You should take Azithromycin either 1 hour before a meal or 2 hours after a meal.
Pregnancy and breast-feeding
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.
Driving and using machines
Azithromycin is not expected to affect your ability to drive or use machines.
3. How to take Azithromycin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The capsules should be swallowed whole.
How much to take
Adults and children with a body weight of 45 kg and above:
The recommended dose is 500 mg (2 capsules) taken together, once a day, for 3 days.
For some diseases such as Chlamydia . Your doctor will ask you to take a single dose of 1000 mg (4 capsules) taken all together on one day only. For gonorrhoea the recommended dose is 1 g or 2 g of azithromycin in combination with 250 or 500 mg of ceftriaxone.
Children and adolescents under 45 kg:
The Azithromycin capsules should not be taken by children weighing less than 45 kg. Young people with a body weight of less than 45 kg should use other forms of this medicine such as azithromycin suspension.
Patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.
Doctors sometimes prescribe different doses to the recommended dose. The label on the pack will tell you which dose you should take. If you are still not sure, ask your doctor or pharmacist.
Always continue with the course even if you feel better. If your infection gets worse or you do not start to feel better within a few days or a new infection develops, go back and see your doctor.
If you take more Azithromycin than you should
If you take more Azithromycin than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Azithromycin
If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose, do not take a double dose to make up for a forgotten dose. If you have to skip a dose, still take all of your capsules. This means that you will finish your course a day later.
If you stop taking Azithromycin
If you stop taking Azithromycin too soon, the infection may return. Take the capsules for the full time of treatment, even when you begin to feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you experience any of the following symptoms after taking this medicine as the symptoms maybe severe- you may need urgent medical treatment:
Stop taking azithromycin if you develop these skin symptoms and contact your doctor or seek medical attention immediately.
The most common side effects that occur when taking Azithromycin are listed below. These may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue to bother you.
Other side effects include:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available data)
If any of the side effects gets serious, or if you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Your doctor may then decide to reduce your dose or stop treatment.
You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Azithromycin
Do not use this medicine after the expiry date which is stated on the packaging after EXP. 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 to protect the environment.
6. Contents of the pack and other information
What Azithromycin contains
The active substance is azithromycin (as dihydrate).
Azithromycin 250 mg capsules contain azithromycin dihydrate equivalent to 250 mg of azithromycin.
The other ingredients are:
Cellulose microcrystalline (E460), Pregelatinised starch (maize), Magnesium stearate (E470b), Sodium laurilsulfate, gelatin, black ink (shellac, propylene glycol, black iron oxide, potassium hydroxide).
What Azithromycin looks like and contents of the pack
Azithromycin 250 mg Capsules consist of a white cap and white body, size “0” hard gelatin opaque capsuls, imprinted in black ink with "250" on cap and body, containing white to off white granular powder.
The capsules are available in blister packages of 2, 4 or 6 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in July 2020
1065018442
12 New Fetter Lane, LONDON, EC4A 1JP, UK
+44 (0)800 090 2408
+44 (0)844 8793 188