Description

1. What Aotocol 8.6mg Tablets are and what they are used for

Aotocol is a laxative used for the short-term relief of occasional constipation.

2. What you need to know before taking Aotocol 8.6mg Tablets

Do not take if you:

– are allergic to senna or any of the other ingredients of this medicine

– have blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or stenosis)

– have paralysis or a lack of muscle tone in the bowel (atony)

– have symptoms of appendicitis, inflammatory bowel disease such as Crohn’s disease or ulcerative colitis

– have severe dehydration

– have already taken a laxative and are still constipated

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aotocol 8.6mg Tablets if:

– senna is needed every day, or abdominal pain persists or worsens

– you have no bowel movements after three days

– you need senna every day and the cause of constipation should be investigated. Long-term use of laxatives should be avoided

– you suffer from kidney disorders

– have faecal impaction or rectal bleeding for which you don’t know the cause, or blood in your stools

– have had a sudden change in bowel habit that has lasted for more than 2 weeks

– have persistent or undiagnosed abdominal complaints e.g. pain, nausea, or vomiting

Other medicines and Aotocol 8.6mg Tablets

Talk to your doctor or pharmacist if you are taking medicines for a heart condition or heart rhythm problems (e.g. cardiac glycosides, antiarrhythmic medicines e.g. quinidine) including medicines which may cause changes to your heart beat (QT prolongation), diuretics (medicine to help you pass urine), adrenocorticosteroids or liquorice root preparations.

You should consult your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, including those listed above and any medicines obtained without prescription.

Pregnancy, breast-feeding and fertility

Do not use this product if you are pregnant or breast-feeding.

When preparations containing senna leaf preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.

It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

3. How to take Aotocol 8.6mg Tablets

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, including the elderly and children aged 12 years and over:

The recommended dose is to swallow 2-4 tablets at night.

Children 6-12 years: 1 tablet once a day.

Children under 6 years of age: Contraindicated.

Do not exceed the stated dose.

Method of administration:

Aotocol 8.6mg Tablets are for oral administration.

Normally it is sufficient to take this medicine product up to two to three times a week. Use for more than 1 week requires medical supervision.

Tell a doctor, pharmacist or nurse if:

– the symptoms worsen, or persist during the use of the medicinal product.

– there is no bowel movement within 3 days of use

– you need to take laxatives every day or if abdominal pain persists.

If you take more than you should:

Consult your doctor and take this leaflet with you. It may be harmful to take too much of this medicine or take it for too long. This is because it may lead to:

– A ‘lazy bowel’, where the muscle in the bowel becomes too relaxed. This means that bowel emptying happens less often. This can lead to long-term constipation.

– Imbalance of fluids and salts in the body. This can affect the tightness of muscles such as those in the bowel. It can also affect the salts in the blood.

– Low levels of potassium in the blood (called hypokalaemia). This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat.

– Dehydration, making you thirsty, feel faint and giving you headaches. It can also mean that you cannot pass enough urine.

If you forget to take a dose: If you miss a dose, take your next dose at the usual time. Do not take two doses at the same time to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any of the following:

– abdominal pain, spasms and diarrhoea, in particular these effects may be experienced by patients with irritable colon. In these cases, a reduction in dose may be necessary.

– hypersensitivity (allergic) reactions, hives (skin bumps), skin itchiness or local or more widespread rash, or asthma.

– can make you more likely to catch infections.

– chronic use may lead to albuminuria and haematuria which is albumin or red blood cells in the urine.

– yellow or red-brown discolouration of urine may occur, which is harmless

– prolonged use may lead to an electrolyte imbalance.

– chronic use may cause pigmentation of the gastrointestinal tract which usually recedes when the product is no longer taken.

– low potassium levels in the blood leading to muscle weakness and/or cramps

– severe weight loss

– changes in the shape of the finger and fingernail, muscular spasms and inflammation of bones and joints

Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Aotocol 8.6mg Tablets

Keep this medicine out of the sight and reach of children. Blisters: Store below 25°C temperature. Store in the original package. Do not use this medicine after the expiry date which is stated on the blister/carton (EXP month/year). This refers to the last day of the month.