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GERMOLOIDS OINTMENT - patient leaflet, side effects, dosage

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Patient leaflet - GERMOLOIDS OINTMENT

1. what germoloids® ointment is and what it is used for

Haemorrhoids (also known as piles) are swollen or enlarged blood vessels, which can cause discomfort, itching and bleeding, particularly after a bowel movement. They may be either internal (inside the anus) or external (outside the anus).

Germoloids Ointment is used to relieve the symptoms of pain, swelling and irritation associated with internal and external haemorrhoids and anal itching (pruritus ani). The ointment contains two active substances, zinc oxide and lidocaine.

Zinc oxide has astringent properties (causes contraction when applied to the skin), which help to shrink swelling. It also helps to soothe and protect the area around the anus from damage and has antiseptic properties.

Lidocaine is a local anaesthetic, which helps to soothe swelling, pain and irritation and relieve itching. The ointment base acts as a lubricant and emollient to help the passing of stools and reduce the straining during bowel movement which is bad for haemorrhoids.

2. what you need to know before you use germoloids® ointment

DO NOT use Germoloids Ointment:

  • If you are allergic (hypersensitive) to zinc oxide or lidocaine, or any of the other ingredients in the product (see section 6).

Warnings and precautions

Before using Germoloids Ointment, talk to your doctor if you:

  • Continually suffer from haemorrhoids or have severe haemorrhoids.
  • Experience excessive bleeding.

Pregnancy and breastfeeding:

You may use Germoloids Ointment if you are pregnant or breastfeeding but as with all medicines at this time, you should discuss it with your doctor first.

Germoloids Ointment contains wool fat and propylene glycol:

This medicine contains 20 mg propylene glycol per 1 g of ointment. It also contains wool fat which may cause local skin reactions (e.g. contact dermatitis).

3. how to use germoloids® ointment

Follow the directions below carefully.

Wash your hands before and after using the ointment.

.Adults and children aged 12 years and over:


2.

3.


Before using the ointment for the first time, check that the tube seal is not broken.

Remove the seal by peeling from the tag.

For external haemorrhoids, apply the ointment directly to the affected area.

For internal haemorrhoids, screw the applicator nozzle onto the tube and smear some of the ointment on the outside of the nozzle to ease application. Carefully insert the applicator into the opening of the anus. Gently squeeze the tube whilst slowly withdrawing the nozzle so that the ointment moves gently up the anus.


MOCKUP

not for production



  • 4. Replace the cap firmly after use. Always keep the tube of ointment, cap and nozzle clean.

'Apply the ointment to the affected area at least twice a day with a minimum of 3 to 4 hours 'between applications. Further applications can be made at any time of the day, and are Iparticularly recommended after a bowel movement. Do not use the ointment more than 4 times in any 24 hour period.

Children under 12: Not recommended unless used under the supervision of a doctor.

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


The ointment is for use in and around the anus only. Do not put the ointment in your mouth or swallow it. If some of the ointment is swallowed accidentally, tell your doctor straight away or contact your nearest Accident and Emergency Department.

4. possible side effects

'Like all medicines, this medicine can cause side effects, although not everybody gets them. 'Rarely, you may experience increased local irritation, burning sensations or rashes at the site lof application after applying the ointment.

ilf you experience any of these symptoms or react badly to the ointment in any other way, stop lUsing this product and tell your doctor or pharmacist immediately.

Reporting of side effects

i|f you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible iside effects not listed in this leaflet. You can also report side effects directly via the Yellow iCard Scheme at: or search for MHRA Yellow Card in the Google iPlay or Apple App Store. By reporting side effects you can help provide more information on.the safety of this medicine.

5. how to store germoloids® ointment

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

iThis product should be stored in its original carton.

iDo not use this medicine after the expiry date which is stated on the carton and on the end of |the tube of ointment. 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 Germoloids Ointment contains:

The active substances are zinc oxide (6.6% w/w) and lidocaine hydrochloride (0.7% w/w).

The other ingredients are yellow soft paraffin, wool fat, methyl salicylate, propylene glycol and 'menthol. See end of Section 2 for wool fat and propylene glycol advice.

What Germoloids Ointment looks like and contents of the pack:

Germoloids Ointment is available in tubes containing 25ml or 55ml of a pale yellow ointment '(not all pack sizes may be marketed).

Marketing Authorisation Holder: Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK.

।Manufacturer: Famar A.V.E. Avion Plant, 49th km National Road Athens-Lamia, Avlona Attiki, 19011, Greece.

How to help reduce the occurrence and/or severity of the condition:

lOonstipation and straining during bowel movement can make haemorrhoids worse. To help lavoid this, the following steps can be taken:

I* Eat a high fibre diet of fruits, vegetables and whole grain food

  • Drink plenty of fluids, at least eight glasses a day (preferably water)
  • Go to the toilet immediately when you need to pass stools and try to avoid straining during

' bowel movement

  • ' Exercise regularly as it can help to stimulate regular bowel movement.

iThis leaflet was last revised in November 2020.

Remember: if you have any doubts about using Germoloids® Ointment correctly, seek the advice of your doctor or pharmacist.

I® Germoloids is a registered trademark.

, ooooooooo Baver