Manevac granules

Main information

  • Trade name:
  • Manevac granules
  • Dosage:
  • 124mg/ 1gram ; 542mg/ 1gram
  • Pharmaceutical form:
  • Granules
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Manevac granules
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 01060200; GTIN: 5060206110007

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 46302/0132
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SPECIFICATION BOX: Beipackzettel

PRODUCT:

MATERIAL-NO.:

MFS-NO.:

LAETUS-CODE:

EAN-CODE:

56UK2149261-01

902338

- - -

SIGHTMARKS:

- - -

PACK-SIZE:

184 x 378 mm

FONT-SIZE:

Avant Garde Gothic 8,8 pt

COUNTRY:

LANGUAGE:

Englisch

CORRECTION:

1. Correction

DATE:

23.02.2018

Black

Manevac Granules 400 g

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

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.

You must talk to a doctor if you do not feel better or if you feel worse after 7 of days.

What is in this leaflet:

1. What Manevac is and what it is used for

2. What you need to know before you take Manevac

3. How to take Manevac

4. Possible side effects

5. How to store Manevac

6. Contents of the pack and other information

1. What Manevac is and what it is used for

Manevac is one of a group of medicines called laxatives. The medicine contains Ispaghula Seed, Ispaghula Husk

(bulk-forming laxatives) and Tinnevelly Senna Pods (a stimulant laxative). Manevac can be used occasionally to relieve

constipation (infrequent passing of hard stools).

Manevac is also used to maintain normal bowel action in bed-ridden patients and pregnant women. Manevac can

also help reduce pain when emptying the bowels for patients suffering from haemorrhoids (piles).

Manevac does not help with weight loss.

2. What you need to know before you take Manevac

Do not take Manevac

if you are allergic to Ispaghula Seed, Ispaghula Husk, Tinnevelly Senna Pods or any of the other ingredients of this

medicine (listed in section 6).

(An allergic reaction can be a rash, itchiness or shortness of breath).

if you have narrowing of the gastrointestinal tract

if you have difficulty in swallowing or any throat problems

if you have a blocked bowel (intestinal obstruction or paralysis of the intestines)

if you suffer from any bowel disorders, for example ulcerative colitis, Crohn’s disease, appendicitis or enlarged bowel

(megacolon)

if you have diabetes which is difficult to control

if you have unexplained tummy pain

if you are severely dehydrated

in children under 12 years of age.

Talk to your doctor before taking this product if any of the above applies to you.

Warnings and precautions

Take each dose of Manevac with 1-2 glasses of water or similar drink, such as milk or fruit juice. Taking Manevac with-

out enough liquid may cause it to swell and block your throat, and may cause choking. If you have chest pain, vomit-

ing, or difficulty in swallowing or breathing after taking Manevac, get medical attention straight away. (See “How to

take Manevac” in section 3.)

Do not exceed the stated dose.

Make sure you drink enough while taking Manevac. This will also help your constipation.

Only take Manevac if your doctor tells you to do so:

if you are weak, frail or elderly (you will need to be monitored while taking Manevac)

if you have a blocked bowel (dried, hard stools with tummy pain, nausea and vomiting).

If you get tummy pain or your stools are different in some way, stop taking Manevac and see your doctor.

If you need to use laxatives every day for your constipation, see your doctor. Do not use laxatives for a long time un-

less your doctor tells you. Using stimulant laxatives (such as Senna pods) more often than occasionally can slow down

your bowel and make your constipation worse (called ’lazy bowel syndrome’).

See your doctor before taking Manevac if you are already taking:

medicines for heart failure or irregular heart beat

any medicines that may affect your heart rhythm (QT-prolongation seen on an ECG trace)

water tablets (diuretics)

certain steroids used for inflammation

liquorice root.

(See also ‘Taking other medicines’ below.)

Talk to your pharmacist or doctor for advice if you have kidney problems.

If you are incontinent, your pads should be changed more frequently.

You should first try taking more exercise, changing your diet or taking bulking agents to relieve your constipation be-

fore taking laxatives. Ask your pharmacist or doctor for advice.

Information for diabetics

Speak to your doctor before taking Manevac if you are diabetic (each measuring spoon or sachet contains approxi-

mately 1.04g of sucrose).

If this applies to you it is important that you speak to your doctor or pharmacist before taking Manevac and they will

decide what to do. It may still be safe for you to take Manevac.

Other medicines and Manevac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines

obtained without a prescription.

In particular tell your doctor or pharmacist about:

mineral or vitamin B12 supplements

medicines for heart failure (cardiac glycosides)

medicines to thin the blood such as warfarin

carbamazepine for epilepsy (fits)

lithium for bipolar disorder.

Do not take Manevac within ½ to 1 hour before or after these medicines.

insulin

If you are diabetic and use insulin, you may need to reduce your dose of insulin if you take Manevac with meals.

medicines for thyroid problems

Your doctor may need to change the dose of the thyroid hormones you are taking.

Long-term misuse of laxatives increases the side effects of:

medicines for heart failure or heart rhythm

water tablets (diuretics)

certain steroids used for inflammation

liquorice root.

It may still be safe for you to take Manevac; your doctor or pharmacist will be able to advise you further.

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. It is best not to use Manevac during the first three months of preg-

(Ispaghula Seed, Ispaghula Husk

and Tinnevelly Senna Pods)

56UK2149261-01_902338.indd 1

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nancy. Manevac should only be used occasionally and only if changes in diet or the use of bulking agents have not worked.

Do not use Manevac if you are breast-feeding as small amounts of some of the ingredients may get into your milk.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.

Driving and using machines

Manevac has no known effect on your ability to drive and use machines.

Important information for patients with an intolerance to some sugars

Manevac contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicine.

3. How to take Manevac

If this product has been prescribed by your doctor, the label on the pack will tell you how much you should take and

when. Always take Manevac exactly as your doctor has told you. If you are pregnant, it is best not to use Manevac

during the first three months of pregnancy. You should check with your doctor or pharmacist if you are not sure about

taking Manevac.

Manevac should be placed dry on the tongue and, without chewing or crushing, swallowed with plenty of water, warm

drink, milk, fruit juice, or similar liquid (approximately 1-2 glasses with each level measuring spoon or sachet).

Drink about 5-10 glasses of fluid every day while you are taking this product.

Dose

Adults (including pregnant women), the elderly and children over 12 years

The usual dose for adults, the elderly and children over 12 years is one or two level measuring spoons OR one or two sachets

(equivalent to 5g or 10g of granules respectively) once a day at night. But do not take it immediately before bedtime.

Take the dose at least ½ to 1 hour before or after taking other medicines.

Take the smallest dose to produce comfortable soft stools.

The maximum daily dose is two level measuring spoons or two sachets (10g of granules) of Manevac.

Normally you will need to take Manevac no more than two or three times a week. Do not use for longer than 1 – 2 weeks

unless your doctor agrees. If the symptoms persist while using Manevac, talk to your doctor or a pharmacist.

(See “Take special care with Manevac” in section 2.)

Use in children and adolescents

Manevac is not recommended for children under 12 years of age.

If you take more Manevac than you should

If you take too much Manevac contact your nearest casualty department or tell your doctor or pharmacist immedi-

ately. Take this leaflet and any remaining granules with you.

It may be harmful to

Take too much Manevac or

Take Manevac for too long

This is because taking too much for too long 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 fluid 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 you cannot pass enough urine.

If you forget to take Manevac

If you forget to take your Manevac, just take your normal dose as soon as you remember. Do not take a double dose to

make up for a forgotten dose.

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.

If you get any of the following side effects you should stop taking Manevac and tell your doctor immediately or go to

the casualty department of your nearest hospital, as these may be signs of an allergic reaction to the medicine:

a skin rash resembling hives (itchy, raised, swollen areas on the skin) or nettle rash

itchiness or redness

shortness of breath

Flatulence (wind) may occur for a short time after starting Manevac.

Manevac may produce tummy pain, tummy cramps and runny stools, in particular in patients with irritable bowel. However,

these symptoms may also occur if too much Manevac has been taken. If this is the case, take less Manevac.

Swollen tummy, blockage in the throat or gut and blocked bowel (dried, hard stools collected in the rectum and anus)

may occur, particularly if insufficient fluid is drunk.

The frequency of these side effects is not known.

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 Yellow Card Scheme (Website: www.yellowcard.mhra.gov.uk). By reporting

side effects you can help provide more information on the safety of this medicine.

5. How to store Manevac

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

Do not use Manevac after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not use this medicine if you notice description of the visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medi-

cines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Manevac contains

The active substances are Ispaghula Seed, Ispaghula Husk and Tinnevelly Senna Pods.

Each 5g dose contains:

2.6g of Ispaghula Seed (Plantago ovata Forssk.);

0.11g of Ispaghula Husk (Plantago ovata Forssk.);

0.34-0.66g of Tinnevelly Senna fruit (Cassia angustifolia Vahl) corresponding to 15mg hydroxyanthracene glycosides

calculated as sennoside B.

The other ingredients are caraway oil, Spanish sage oil, peppermint oil, acacia, talc, iron oxides (E172), hard paraffin,

liquid paraffin and sucrose.

What Manevac looks like and contents of the pack

Manevac is presented as brown sugar-coated granules and is available in

packs containing 400g of granules

Marketing Authorisation Holder and Manufacturer

Mylan Products Ltd. Station Close, Potters Bar, Hertfordshire, EN6 1TL,United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

HFA Healthcare Limited

Solihull, B91 1NF, UK

Tel: 0844 335 8270.

Manevac is a registered Trade Mark

This leaflet was last revised in February 2018.

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